ORLANDO, FL / ACCESSWIRE / June 20, 2024 / Nutriband Inc.("Company") (NASDAQ:NTRB)(NASDAQ:NTRBW) provides an update on its Aversa Fentanyl product development program to shareholders as it aims to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to NDA filing.
- As previously reported, the Company with its partner Kindeva Drug Delivery completed the feasibility agreement and entered into a commercial development and clinical supply agreement to manufacture product for the human abuse potential clinical study in support of a New Drug Application (NDA) to be submitted to FDA. The feasibility agreement was focused on adapting Kindeva's commercial transdermal manufacturing process to incorporate AVERSA™ abuse deterrent transdermal technology.
- Nutriband is currently working with its partner Kindeva Drug Delivery to develop the commercial scale manufacturing process for the final product which will incorporate Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system.
- Recently, Kindeva Drug Delivery completed the validation of the aversive agent cleaning analytical methods required to allow work with the aversive agents, denatonium benzoate and capsaicin, on the commercial manufacturing line.
- Once the final commercial product manufacturing process is completed, Nutriband intends to file an IND with the FDA and perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance.
- Nutriband will file an Investigational New Drug (IND) application with the FDA prior to conducting the single Phase 1 human abuse potential clinical study required for its NDA. The IND will include the chemistry, manufacturing, and controls (CMC) information for the commercial product as well as the clinical study protocol for the human abuse potential study.
- No Phase 2 or phase 3 Clinical Trials are required prior to submitting for approval.
- AVERSA(TM) Fentanyl is estimated to have the potential to reach peak annual US sales of $80 million to $200 million, according to a market analysis report from Health Advances(1).
The pivotal laboratory assessment to be conducted is a series of in vitro manipulation and extraction studies designed to determine if the potentially abuse-deterrent properties of the product can be defeated or compromised based on physical and chemical manipulation of the product. Preliminary studies conducted to date have shown that the AVERSA technology is very difficult to defeat by various physical or chemical means.
The pivotal clinical study is a human abuse potential study performed to assess the impact of the potentially abuse-deterrent properties in a drug-experienced, recreational user population. The human abuse potential study is a randomized, double-blind, placebo-controlled and positive controlled crossover study comparing AVERSA Fentanyl to the currently marketed fentanyl patch which does not contain abuse-deterrent technology. The success of the human abuse potential study is based on the assessment drug liking using various instruments that are predictive of the likelihood of abuse.
Nutriband's AVERSA™ abuse-deterrent technology incorporates 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.
(1) Health Advances Aversa Fentanyl market analysis report 2022
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 deterrence 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.
About Kindeva
Headquartered in Woodbury, Minnesota, Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, intradermal drug delivery (microneedles) and connected drug delivery. Kindeva employs approximately 1,000 people worldwide. For more information, visit www.kindevadd.com.
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, 2024 and Forms 10-Q, 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.
For more information, contact:
RedChip Companies, Inc.
Email: [email protected]
Phone: 1-407-644-4256
Address:
431 E Horatio Ave, Suite #100
Maitland, FL 32751
Nutriband Inc.
Phone: 407-377-6695
Email: [email protected]
SOURCE: Nutriband Inc.