What changed in this filing

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Item 1. Business

2025-04-28 compared with 2024-05-01 · 181 added, 183 removed, 393 unchanged (48% of the section changed)

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of transdermal pharmaceutical products.

Our development pipeline consists of transdermal products that are based on our proprietary AVERSA ™

abuse deterrent transdermal technology that we believe can be incorporated into existing transdermal patches that contain drugs that are

susceptible to abuse and misuse such as opioid and stimulant drugs.

Our development pipeline primarily consists of transdermal products that are based on our proprietary

AVERSA ™ abuse deterrent transdermal technology that we believe can be incorporated into existing transdermal patches

that contain drugs that are susceptible to abuse and misuse such as opioid and stimulant drugs.

The Company’s revenues are based on providing

services through our subsidiaries Pocono Pharmaceuticals operating as Active Intelligence and 4P Therapeutics.

Pocono Pharmaceuticals provides

contract manufacturing services for health, wellness and over-the-counter pharmaceutical customers and 4P Therapeutics performs contract

research and development related services for pharmaceutical and medical devices customers.

We manage and evaluate our operations, and

report our financial results, through these two separate subsidiaries.

Pocono Pharmaceuticals

provides contract manufacturing services for health, wellness and over-the-counter pharmaceutical customers and 4P Therapeutics performs

contract research and development related services for pharmaceutical and medical devices customers.

We manage and evaluate our operations,

and report our financial results, through these two separate subsidiaries.

Our principal offices are located in Orlando,

Florida, and our subsidiary, Pocono Pharmaceuticals, has a manufacturing facility in Cherryville, North Carolina.

We primarily operate and derive

most of our revenues in the United States.

Recent Development

We primarily operate

and derive most of our revenues in the United States.

Recent Developments

On February 13, 2025, we signed an addendum to

the Commercial Development and Clinical Supply Agreement for our lead product, Aversa™ Fentanyl, being developed with our partner,

Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination

Nutriband and Kindeva have revised their agreement to formalize their exclusive product development partnership and long-term

commitment based on shared development costs in exchange for milestone payments.

The development work being conducted under this agreement

supports the development of Nutriband’s AVERSA™ abuse-deterrent technology in general, which can be utilized to incorporate

aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential

including opioids and stimulants.

On April 19, 2024, the Company completed an $8,400,000

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The Offering was made solely to investors resident outside the United

States and was not registered under the Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of

any jurisdiction, including any jurisdiction outside the United States, but was made privately by the Company pursuant to the exemptions

States and was not registered under the Securities Act of 1933, as amended (the “Securities Act”), or the securities laws

of any jurisdiction, including any jurisdiction outside the United States, but was made privately by the Company pursuant to the exemptions

from registration provided in the SEC’s Regulation S and other exemptions under the Securities Act.

AVERSA Abuse Deterrent Transdermal Products

Our lead product under development is AVERSA

Fentanyl, an abuse deterrent fentanyl transdermal system that combines an approved generic fentanyl patch with our AVERSA abuse

deterrent transdermal technology to reduce the abuse and misuse of fentanyl patches.

We believe that our AVERSA technology can be

broadly applied to various transdermal products, and our plan is to follow the development of AVERSA Fentanyl with the development

of additional abuse deterrent transdermal products for pharmaceuticals that have a risk or history of abuse, misuse or accidental

Specifically, we have expanded our development pipeline to include AVERSA Buprenorphine and AVERSA Methylphenidate.

addition, we are developing a portfolio of transdermal pharmaceutical products to deliver already approved drugs or biologics that

are typically delivered by injection but with the potential to improve compliance and therapeutic outcomes through transdermal

Our lead product under development is AVERSA Fentanyl,

an abuse deterrent fentanyl transdermal system that combines an approved generic fentanyl patch with our AVERSA abuse deterrent transdermal

technology to reduce the abuse and misuse of fentanyl patches.

We believe that our AVERSA technology can be broadly applied to various

transdermal products, and our plan is to follow the development of AVERSA Fentanyl with the development of additional abuse deterrent

transdermal products for pharmaceuticals that have a risk or history of abuse, misuse or accidental exposure.

Specifically, we have expanded

our development pipeline to include AVERSA Buprenorphine and AVERSA Methylphenidate.

In addition, we are developing a portfolio of

transdermal pharmaceutical products to deliver already approved drugs or biologics that are typically delivered by injection but with

the potential to improve compliance and therapeutic outcomes through transdermal delivery.

In January 2024, we signed a commercial development

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The development program

is based on the fact that the fentanyl transdermal system is already approved and the only change to the approved product will be to

incorporate the AVERSA technology into the patch design with no change being made to the fentanyl drug matrix or its demonstrated safety,

patch performance or drug release characteristics.

Preclinical studies to be performed consist of laboratory-based in vitro manipulation

and chemical extraction studies per FDA guidance.

Clinical evaluation consists of a Phase 1 human abuse potential study to demonstrate

the abuse potential of the product per FDA guidance.

The regulatory path to FDA approval is planned to be a 505(b)(2) NDA submission

to access the safety and efficacy information on file for the Duragesic ® fentanyl transdermal system as the reference-listed

drug and to be able to obtain approval for abuse deterrent claims as a branded pharmaceutical product.

is based on the fact that the fentanyl transdermal system is already approved and the only change to the approved product will be to incorporate

the AVERSA technology into the patch design with no change being made to the fentanyl drug matrix or its demonstrated safety, patch performance

or drug release characteristics.

Laboratory studies to be performed consist of in vitro manipulation and chemical extraction studies per

FDA guidance.

Clinical evaluation consists of a Phase 1 human abuse potential study to demonstrate the abuse potential of the product

per FDA guidance.

The regulatory path to FDA approval is planned to be a 505(b)(2) NDA submission to access the safety and efficacy information

on file for the Duragesic ® fentanyl transdermal system as the reference-listed drug and to be able to obtain approval for

abuse deterrent claims as a branded pharmaceutical product.

The product development program for the additional

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the owner of 4P Therapeutics.

The purchase price of $2,250,000, consisting of 62,500 shares of common stock, valued at $1,850,000, and

cash of $400,000, and are to pay Mr.

Damon a 6% royalty on any revenue we receive or derive from our utilization or sale of the abuse

deterrent intellectual property that we acquired as a part of the assets 4P Therapeutics, including partner license milestones and development

The royalty is payable pursuant to the acquisition agreement and continues as long as we generate revenue from our utilization

or sale of the abuse deterrent intellectual property we acquired as part of the acquisition of 4P Therapeutics.

The 62,500 shares were

issued to Mr.

The purchase price of $2,250,000 consisted of 62,500 shares of common stock, valued at $1,850,000, and cash

The acquisition agreement requires that we pay Mr.

Damon a 6% royalty on any revenue we receive or derive from our utilization

or sale of the abuse deterrent intellectual property that we acquired as a part of the assets 4P Therapeutics, including partner license

milestones and development payments.

The 62,500 shares were issued to Mr.

Damon (41,750 shares pre-split) and Dr.

Alan Smith (20,750 shares pre-split).

Alan Smith (20,750 shares

In connection with the acquisition, Mr.

retained any cash and accounts receivable and assumed any liabilities other than those relating to the ongoing business.

the acquisition agreement, we appointed Mr.

Damon to our board of directors in April 2018, when we signed the acquisition agreement.

Damon retained any cash and accounts receivable and assumed any liabilities other

than those relating to the ongoing business.

Pursuant to the acquisition agreement, we appointed Mr.

Damon to our board of directors in

April 2018, when we signed the acquisition agreement.

Damon resigned as a director in January 2022.

As a result of the acquisition, the focus of

our business changed from the development and marketing outside of the U.S.

of consumer transdermal products to the development of 4P

Therapeutics’ portfolio of pharmaceutical transdermal products.

Our lead product under development is AVERSA ® Fentanyl

(abuse deterrent fentanyl transdermal system) which we plan to develop to deter the abuse and accidental misuse of fentanyl transdermal

Fentanyl is a potent synthetic opioid that is marketed as a transdermal patch for chronic pain management.

There are currently

several generic fentanyl patches on the market but none of them have abuse deterrent properties.

We believe that AVERSA Fentanyl, once

approved by the US FDA will significantly deter the abuse and accidental misuse of fentanyl transdermal patches.

As a result of the acquisition, the focus of our

business changed from the development and marketing outside of the U.S.

of consumer transdermal products to the development of 4P Therapeutics’

portfolio of pharmaceutical transdermal products.

Our lead product under development is AVERSA ® Fentanyl (abuse deterrent

fentanyl transdermal system) which we plan to develop to deter the abuse and accidental misuse of fentanyl transdermal patches.

is a potent synthetic opioid that is marketed as a transdermal patch for chronic pain management.

There are currently several generic

fentanyl patches on the market but none of them have abuse deterrent properties.

We believe that AVERSA Fentanyl, once approved by the

FDA will significantly deter the abuse and accidental misuse of fentanyl transdermal patches.

With the acquisition of 4P Therapeutics, we acquired

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believe we can take significant market share with good profit margins.

The prioritization of our portfolio product candidates will be

reviewed on an ongoing basis and will take into account technical progress, market potential and R&D funding available.

assure you that we will be able to develop and obtain FDA approval for any of these potential products or that we can be successful in

marketing any such products.

The FDA approval process can take many years to complete successfully, and we will require substantial funding

for each product that goes through the process.

We cannot assure you that we will obtain FDA marketing approval for any of our products.

The prioritization of our portfolio product candidates

will be reviewed on an ongoing basis and will take into account technical progress, market potential and R&D funding availability.

We cannot assure you that we will be able to develop and obtain FDA approval for any of these potential products or that we can be successful

in marketing any such products.

The FDA approval process can take many years to complete successfully, and we will require substantial

funding for each product that goes through the process.

We cannot assure you that we will obtain FDA marketing approval for any of our

In addition to performing research and development

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Pharmaceutical Products in Development

We have a pipeline of transdermal

pharmaceutical products that are primarily in the early stages of development.

Our current focus is on developing our AVERSA abuse

deterrent transdermal patch products.

Our lead product is AVERSA Fentanyl for which we have a commercial development agreement with

Kindeva Drug Delivery, a contract development and manufacturing organization.

We plan to follow on from this with the development of

additional products utilizing the AVERSA abuse deterrent transdermal technology, namely, AVERSA Buprenorphine and AVERSA

Methylphenidate.

We have a pipeline of transdermal pharmaceutical

products that are primarily in the early stages of development.

Our current focus is on developing our AVERSA abuse deterrent transdermal

patch products.

Our lead product is AVERSA Fentanyl for which we have a commercial development agreement with Kindeva Drug Delivery, a

contract development and manufacturing organization.

We plan to follow on from this with the development of additional products utilizing

the AVERSA abuse deterrent transdermal technology, namely, AVERSA Buprenorphine and AVERSA Methylphenidate.

Transdermal patches containing opioid and stimulant

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exposure to medication is a leading cause of poisoning in children.

Young children, in particular, have died or become seriously ill after

being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever.

Children can overdose on new and used fentanyl patches

by putting them in their mouth or sticking the patches on their skin.

This can cause death by slowing the child’s breathing and decreasing

the levels of oxygen in their blood.

Young children, in particular, have died or become seriously ill

after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever.

Children can overdose on new and used fentanyl

patches by putting them in their mouth or sticking the patches on their skin.

This can cause death by slowing the child’s breathing

and decreasing the levels of oxygen in their blood.

We believe that our abuse deterrent technology

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We plan to develop transdermal delivery

systems for buprenorphine and methylphenidate after we make significant progress on our abuse deterrent fentanyl transdermal system.

systems for buprenorphine and methylphenidate as research and development funding becomes available.

Our research pipeline consists primarily of drug

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has the potential to improve compliance, which can lead to improved therapeutic outcomes associated with these treatments.

In most cases,

we plan to utilize the 505(b) (2) NDA regulatory pathway provided by the FDA which allows us to reference the safety information

on file at FDA for the approved drug or to reference the published literature instead of having to generate new safety information that

would typically be required for new chemical entities.

However, we cannot assure you that the FDA will concur with our approach or that

we will be able to receive FDA approval to market any of products that we develop.

In addition, we may seek to develop certain generic

transdermal products where we think we can efficiently make an improvement to existing patches and potentially take significant market

share with good profit margins.

we may seek to develop certain generic transdermal products where we think we can efficiently make an improvement to existing patches

and potentially take significant market share with good profit margins.

In most cases, we plan to utilize the 505(b) (2)

NDA regulatory pathway provided by the FDA which allows us to reference the safety information on file at FDA for the approved drug or

to reference the published literature instead of having to generate new safety information that would typically be required for new chemical

However, we cannot assure you that the FDA will concur with our approach or that we will be able to receive FDA approval to

market any of products that we develop.

The prioritization of our portfolio of product

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Manufacturing of our pharmaceutical transdermal

products in development will be performed in compliance with FDA current Good Manufacturing Practices (cGMP) and all applicable local

regulations by contract manufacturers.

All manufacturing processes and facilities will be subject to review by the FDA during development,

prior to approval and during subsequent routine FDA inspections.

We plan to continue to rely on contract manufacturers and, potentially,

collaboration partners to manufacture commercial quantities of our products, if and when approved for marketing by the FDA.

products will be performed in compliance with FDA current Good Manufacturing Practices (cGMP) and all applicable local regulations.

manufacturing processes and facilities will be subject to review by the FDA during development, prior to approval and during subsequent

routine FDA inspections.

We plan to continue to rely on contract manufacturers and, potentially, collaboration partners to manufacture

commercial quantities of our products, if and when approved for marketing by the FDA.

1 https://www.fda.gov/consumers/consumer-updates/accidental-exposures-fentanyl-patches-continue-be-deadly-children

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prior to marketing and distributing a drug in the United States generally involves a preclinical phase followed by three phases of clinical

The definition of drug is broadly defined and includes the pharmaceutical products we have in development.

Even though the drug

used in each of our proposed products is currently approved by the FDA in other dosage forms, we will still need to conduct a development

program that will include preclinical and clinical trials before we receive FDA marketing approval.

The FDA also has a number of abbreviated

approval pathways which, if we are eligible, could shorten the time for approval.

For example, the regulatory path for the AVERSA products

in development is intended to follow a 505(b)(2) NDA regulatory pathway which may reduce the amount of clinical work that needs to be

performed to a single trial to evaluate the abuse potential of the product as the safety and efficacy of the drug has already been established.

However, we cannot be certain that we will be able to use any abbreviated approval pathway, in which event we will need to comply with

the full regulatory pathway as described below.

trials which culminates in a New Drug Application (NDA) to the FDA for approval.

The definition of drug is broadly defined and includes

the pharmaceutical products we have in development.

Even though the drug used in each of our proposed products is currently approved by

the FDA in other dosage forms, we will still need to conduct a development program that will include preclinical and clinical trials before

we receive FDA marketing approval.

The FDA also has a number of abbreviated approval pathways which, if we are eligible, could shorten

the time for approval.

For example, the regulatory path for the AVERSA products in development is intended to follow a 505(b)(2) NDA regulatory

pathway which may reduce the amount of clinical work that needs to be performed to a single trial to evaluate the abuse potential of the

product as the safety and efficacy of the drug has already been established.

However, we cannot be certain that we will be able to use

any abbreviated approval pathway, in which event we will need to comply with the full regulatory pathway as described below.

In general, the full NDA product development program

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Nutriband plans to utilize the 505(b)(2) New Drug

Application (NDA) regulatory pathway which limits the development required for products that contain drugs that have already been approved,

and allows applicants to reference data already on file at the FDA.

As a result, the NDA application will be primarily based on a single

Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed.

A clinical abuse potential study is typically

performed in recreational drug abusers and is designed to demonstrate that the abuse-deterrent product is less preferable to recreational

drug abusers than conventional fentanyl patches which contain no abuse-deterrent technology.

Application (NDA) regulatory pathway for Aversa Fentanyl which limits the development required for products that contain drugs that have

already been approved, and allows applicants to reference data already on file at the FDA.

As a result, the NDA application will be primarily

based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed.

A clinical abuse potential

study is typically performed in recreational drug abusers and is designed to demonstrate that the abuse-deterrent product is less preferable

to recreational drug abusers than conventional fentanyl patches which contain no abuse-deterrent technology.

Following a successful Phase 1 clinical abuse

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Intellectual Property

The AVERSA abuse deterrent technology

utilized in our AVERSA product pipeline is covered by an international intellectual property portfolio with patents issued in 45

countries including the United States, Europe, Japan, Korea, Russia, Mexico, Canada, and Australia and pending in China and Hong Kong.

patents provide patent coverage to 2035.

The AVERSA abuse deterrent technology utilized

in our AVERSA products is covered by an international intellectual property portfolio with patents issued in 46 countries including the

United States, Europe, Japan, Korea, Russia, Mexico, Canada, Australia, and China including the special administrative regions Hong Kong

These patents provide patent coverage to 2035.

We continue to build on our proprietary positions in the United States and internationally

for our product candidates AVERSA Fentanyl, AVERSA Buprenorphine and AVERSA Methylphenidate as well as other products and technology

that we may have in development.

Our policy is to pursue, maintain and defend patent rights developed internally or acquired

externally and to protect the technology, inventions and improvements that are commercially important to the development of our

We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to

any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents granted to us

in the future will be commercially useful in protecting our technology.

We also may rely on trade secrets to protect our commercial

products and product candidates.

for our product candidates AVERSA Fentanyl, AVERSA Buprenorphine and AVERSA Methylphenidate as well as other products and technology that

we may have in development.

Our policy is to pursue, maintain and defend patent

rights developed internally or acquired externally and to protect the technology, inventions and improvements that are commercially important

to the development of our business.

We cannot be sure that patents will be granted with respect to any of our pending patent applications

or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents

granted to us in the future will be commercially useful in protecting our technology.

We also may rely on trade secrets to protect our

commercial products and product candidates.

Our commercial success also depends in part on our non-infringement of the patents or proprietary

rights of third parties.

On September 19, 2023, the United States Patent

and Trademark Office (USPTO) granted US Patent No.

11,759,431 for Nutriband’s proprietary AVERSA abuse deterrent technology utilizing

taste aversion to address the primary routes of abuse of opioid based transdermal patches.

The issuance of this patent, entitled, “Abuse

and Misuse Deterrent Transdermal Systems,” further expands Nutriband’s intellectual property protection in the United States for

its portfolio of AVERSA abuse deterrent transdermal products.

Further, we plan to seek trademark protection

in the United States and internationally where available and when appropriate.

Further, we plan to seek trademark protection in the United States

and internationally where available and when appropriate.

We have registered the name Nutriband in the United States.

We have filed an intent to use Trademark application for AVERSA.

The USPTO will require us to show the mark used in commerce prior

to fully registering the trademark.

We have filed an

intent to use Trademark application for AVERSA.

The USPTO will require us to show the mark used in commerce prior to fully registering

the trademark.

Scientific Publications

On March 8, 2024, Nutriband presented data on

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(https://www.radars.org/).

2 Olsen, H, Mogusu, E, Black, JC, Sumbundu, K, Dart, RC.

center exposure calls involving fentanyl, buprenorphine, and methylphenidate transdermal patches in the United States.

Poster presented

at the 40th Annual Meeting of the American Academy of Pain Medicine;

2024 Mar 7-10;

Scottsdale, Arizona.

https://www.radars.org/system/publications/39.%20Olsen.pdf

The data indicate that transdermal patch abuse

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Market Assessment

The company engaged leading healthcare consulting company Health Advances

to assess the market opportunity and commercial strategy for AVERSA Fentanyl and AVERSA Buprenorphine.

AVERSA Fentanyl is the lead AVERSA product under development and has

the potential to be the world’s first fentanyl transdermal systems with abuse deterrent properties.

Once approved by the United States

FDA, Aversa Fentanyl will be priced competitively with the non-abuse deterrent patch and has the potential to reach peak annual US sales

of $80-200 million according to the assessment performed by Health Advances in January 2022.

This assessment did not include the impact

of the revised CDC Opioid Prescribing Guidelines which were published in November 2022 that encouraged prescribers to implement comprehensive

and holistic pain management including responsible opioid use particularly for patients with moderate to severe chronic pain.

Health Advances

was able to confirm the significant unmet patient need for AVERSA Fentanyl based on rigorous primary and secondary market research accompanied

with deep experience in the abuse deterrence pain space.

Nutriband is also considering developing the product for strategic international

markets as protected by its global abuse deterrent patent portfolio.

2 Olsen, H, Mogusu, E, Black, JC, Sumbundu, K, Dart, RC.

Poison center exposure calls involving

fentanyl, buprenorphine, and methylphenidate transdermal patches in the United States.

Poster presented at the 40th Annual Meeting

of the American Academy of Pain Medicine;

2024 Mar 7-10;

Scottsdale, Arizona.

https://www.radars.org/system/publications/39.%20Olsen.pdf

AVERSA Buprenorphine is the second AVERSA product under development

and has the potential to be the world’s first buprenorphine transdermal systems with abuse deterrent properties.

Once approved by the

United States FDA, Aversa Buprenorphine will be priced competitively with non-abuse deterrent options and has the potential to reach peak

annual US sales of $70-130 million according to the assessment performed by Health Advances in October 2023.

Health Advances was able

to confirm the significant unmet patient need for Aversa™ Buprenorphine based on rigorous primary and secondary market research

accompanied with deep experience in the abuse deterrence pain space.

Nutriband is also considering developing the product for strategic

international markets as protected by its global abuse deterrent patent portfolio.

The company engaged leading healthcare consulting

company Health Advances to assess the market opportunity and commercial strategy for AVERSA™ Fentanyl and AVERSA™ Buprenorphine.

AVERSA Fentanyl is the lead AVERSA product under

development and has the potential to be the world’s first fentanyl transdermal system with abuse deterrent properties.

Once approved

by the United States FDA, Aversa Fentanyl will be priced competitively with the non-abuse deterrent patches currently on the market and

has the potential to reach peak annual US sales of $80-200 million according to the assessment performed by Health Advances in January

This assessment did not include the impact of the revised CDC Opioid Prescribing Guidelines which were published in November 2022

that encouraged prescribers to implement comprehensive and holistic pain management including responsible opioid use particularly for

patients with moderate to severe chronic pain.

Health Advances was able to confirm the significant unmet patient need for AVERSA Fentanyl

based on rigorous primary and secondary market research accompanied with deep experience in the abuse deterrence pain space.

is also considering developing the product for strategic international markets as protected by its global abuse deterrent patent portfolio.

AVERSA Buprenorphine is the second AVERSA product

under development and has the potential to be the world’s first buprenorphine transdermal system with abuse deterrent properties.

Once approved by the United States FDA, Aversa Buprenorphine will be priced competitively with non-abuse deterrent options and has the

potential to reach peak annual US sales of $70-130 million according to the assessment performed by Health Advances in October 2023.

Advances was able to confirm the significant unmet patient need for Aversa Buprenorphine based on rigorous primary and secondary market

research accompanied with deep experience in the abuse deterrence pain space.

Nutriband is also considering developing the product for

strategic international markets as protected by its global abuse deterrent patent portfolio.

The pharmaceutical industry is highly competitive

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the United States.

Pharmaceutical companies engaged in the distribution and sale of opioids, in particular for the treatment of chronic

pain, are promoting responsible opioid use.

In 2022, the CDC revised its clinical practice guideline for prescribing opioids to ease the

restrictions on prescribers and encourage responsible opioid use particularly for patients with moderate to severe pain.

Our abuse deterrent

opioid products potentially offer a unique proposition to meet the unmet needs of patients by deterring the abuse and misuse of opioids

while making opioids accessible to those patients who need them.

If approved, our AVERSA pipeline products will compete with the currently

marketed products that do not contain abuse deterrent features as well as other products that may employ different abuse deterrent technology.

We may also have to compete with products that do not contain opioids or other drugs that are susceptible to abuse.

We are not aware of

any abuse deterrent transdermal products that are in development or being marketed at this time.

If we obtain regulatory approval to market

our products, we cannot assure you that we will be successful in the marketplace.

It is important that pharmaceutical companies engaged in the distribution and sale of opioids, in particular for the

treatment of chronic pain, promote responsible opioid use.

In 2022, the CDC revised its clinical practice guideline for prescribing opioids

to ease the restrictions on prescribers and encourage responsible opioid use particularly for patients with moderate to severe pain.

abuse deterrent opioid products potentially offer a unique proposition to meet the unmet needs of patients by deterring the abuse and

misuse of opioids while making opioids accessible to those patients who need them.

If approved, our AVERSA pipeline products will compete

with the currently marketed products that do not contain abuse deterrent features as well as other products that may employ different

abuse deterrent technology.

We may also have to compete with products being developed that do not contain opioids or drugs that are susceptible

We are not aware of any abuse deterrent transdermal products that are in development or being marketed at this time.

regulatory approval to market our products, we cannot assure you that we will be successful in the marketplace.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business