Nutriband Provides Clinical and Regulatory Path Overview for Lead Product - AVERSA(R) Fentanyl Transdermal Patch
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Insights
The use of the 505(b)(2) regulatory pathway for Nutriband's AVERSA™ Fentanyl represents a strategic move that could significantly expedite the drug's time-to-market. This pathway allows for a potentially faster approval process by referencing existing safety and efficacy data from previously approved drugs, which in this case is the FDA-approved fentanyl patch. The decision to forgo Phase 2 and 3 trials, relying instead on a Phase 1 human abuse potential clinical study, highlights a confidence in the abuse-deterrent technology's ability to meet regulatory standards. However, this approach also carries inherent risks, as it may raise concerns about the comprehensiveness of safety data. Stakeholders should monitor the FDA's response to the submission, as any requests for additional data could delay approval and impact projected sales figures.
From a medical research perspective, the focus on abuse-deterrent properties in AVERSA™ Fentanyl addresses a critical public health issue related to opioid abuse. The single Phase 1 human abuse potential clinical study is designed to prove that the patch is less appealing to recreational users, which could have a significant impact on reducing misuse. However, the estimated sales potential of $80 million to $200 million must be viewed in the context of the broader opioid market, which was valued at $22.8 billion in 2022. The projected figures suggest a modest market penetration, possibly due to the niche focus on abuse deterrence. Long-term success will likely depend on the product's ability to demonstrate a clear advantage in safety without compromising efficacy.
Analyzing the market implications of Nutriband's announcement, the projected sales figures for AVERSA™ Fentanyl suggest a significant opportunity within the opioid market. The partnership with Kindeva Drug Delivery could enhance the product's credibility and facilitate manufacturing scalability. However, investors should consider the broader market dynamics, including competitive products, payer reimbursement policies and evolving regulations around opioid prescriptions. The potential for expedited FDA review is promising, but market adoption will ultimately be influenced by the product's perceived value in addressing abuse and misuse, which has become an increasingly important factor in the opioid segment.
NDA will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed prior to submission.
AVERSA™ Fentanyl incorporates Nutriband's Aversa™ abuse-deterrent technology with an FDA-approved fentanyl patch and is being developed via a limited 505(b)(2) New Drug Application (NDA) pathway.
ORLANDO, FL / ACCESSWIRE / March 27, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today provided an overview of the clinical development and regulatory pathway for its lead product, AVERSA™ Fentanyl, an abuse-deterrent fentanyl transdermal patch.
Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. As Nutriband's abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation are not required.
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.
Following a successful Phase 1 clinical abuse potential study, Nutriband intends to file a 505(b)(2) NDA to the FDA for marketing approval of AVERSA™ Fentanyl, which has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The AVERSA™ Fentanyl NDA has the potential to receive an expedited review by FDA as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.
Combined, the clinical development and regulatory path for AVERSA™ Fentanyl is substantially limited compared to conventional pharmaceutical product development, requiring only a single clinical trial and, following a limited NDA pathway, undergoing an expedited review by the FDA.
AVERSA™ Fentanyl is estimated to have the potential to reach peak annual US sales of
Nutriband is developing its proprietary AVERSA™ abuse deterrent transdermal technology to be incorporated into any transdermal patch that contains a drug with a risk of abuse, misuse, or accidental exposure. The Company's AVERSA™ product development pipeline includes abuse deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure.
1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband's AVERSA™ abuse-deterrent transdermal technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2023, filed April 26, 2023, the Forms 10-Q's filed subsequent to the Form 10-K in 2023, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Contact Information:
Investor Relations
RedChip Companies Inc.
Dave Gentry
Email: Info@redchip.com
Phone: 1-800-RED-CHIP (733-2447)
or 407-491-4498
Nutriband Inc.
Phone: 407-377-6695
Email: Support@nutriband.com
SOURCE: Nutriband Inc.
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FAQ
What is the name of the abuse-deterrent fentanyl transdermal patch developed by Nutriband Inc.?
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What type of clinical trials are not required for the submission of AVERSA™ Fentanyl NDA?
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