Nutriband COO Alan Smith Ph.D. Selected for FDA Center for Research on Complex Generics Stakeholder Expert Committee
Nutriband Inc. (NASDAQ:NTRB, NTRBW) announced on March 2, 2023, that Alan Smith, Ph.D., COO and President of its subsidiary, 4P Therapeutics, was appointed to the FDA's Center for Research on Complex Generics Stakeholder Expert Committee on Adhesion Testing for transdermal delivery systems. This committee aims to enhance collaboration between the FDA and industry for developing safe generic products. Dr. Smith brings over 25 years of expertise in transdermal drug delivery systems. Nutriband focuses on developing innovative transdermal products, including its abuse-deterrent fentanyl patch, using proprietary AVERSA™ technology.
- Alan Smith's appointment to the FDA committee enhances Nutriband's credibility in drug delivery.
- The FDA's CRCG initiative aligns with Nutriband's focus on complex drug products.
- Nutriband's AVERSA™ technology addresses a significant market need by improving safety in pain management.
- None.
ORLANDO, FL / ACCESSWIRE / March 2, 2023 / Nutriband Inc. (the "Company") (NASDAQ:NTRB)(NASDAQ:NTRBW) today announced that Alan Smith, Ph.D., Chief Operating Officer (COO), Nutriband, and President of its subsidiary, 4P Therapeutics LLC ("4P Therapeutics"), has been selected for the FDA's Center for Research on Complex Generics Stakeholder Expert Committee on Adhesion Testing for Transdermal/Topical Delivery Systems.
The Center for Research on Complex Generics (CRCG) was established by FDA in 2020 to enhance research collaborations with industry to further the FDA's mission of increasing access to safe and effective generic products. This goal will be pursued through collaborative research, training, and exchange of resources between FDA, industry, and stakeholders.
Complex drug products, which are a key component of the FDA's Drug Competition Action Plan, are medical products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement, such as transdermal patches and drug-device combination products.
Dr. Smith has over 25 years of experience in the development of transdermal drug delivery systems, noninvasive medical devices and wearable diagnostics with specialized experience in conducting clinical proof-of-concept studies and developing in vitro tests that correlate to in vivo performance in the clinic.
"It is a privilege to be selected for this FDA CRCG Stakeholder Expert Committee. The currently utilized in vitro methods for transdermal adhesion testing are inadequate in predicting performance in the clinic and I am excited about the possibility of helping to advance the state of the art in this field," said Alan Smith, Ph.D., President, 4P Therapeutics.
To learn more about the FDA's Center for Complex Generics, see https://www.fda.gov/drugs/guidance-compliance-regulatory-information/center-research-complex-generics
About 4P Therapeutics
4P Therapeutics is a subsidiary of Nutriband, Inc. primarily focused on the research and development of novel drug delivery technologies and therapeutics. 4P develops products that meet the needs of patients, physicians and payers (the 4P's). A key company focus and area of expertise is in the development of transdermal products based on a wide range of technologies from conventional small molecule patches to novel transdermal technologies for delivery of proteins, peptides, macromolecules and biologics. Transdermal delivery of commercially available drugs or biologics that are typically delivered via injection has the potential to improve safety, efficacy and therapeutic outcomes associated with these treatments.
4P specializes in accelerating early stage product development from initial concept to proof-of-concept in humans, by moving quickly from the establishment of preclinical feasibility to demonstration of product feasibility in human clinical trials. 4P supports partners throughout the product development program with specific expertise in planning and execution of the clinical research program as well developing and executing the regulatory plan to meet the requirements of the United States Food and Drug Administration (FDA).
The Company's website is www.4ptherapeutics.com. Any material contained in or derived from 4P Therapeutics' website or any other website is not part of this press release.
About Nutriband Inc.
Nutriband Inc. (NASDAQ:NTRB) is 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. Nutriband's AVERSA™ abuse-deterrent 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.
The Company's website is www.nutriband.com. Any material contained in or derived from the Company's website 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 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, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Phase 1b study might not be replicated), 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, Annual Report on Form 10-K for the year ended January 31, 2022 and subsequent Quarterly Reports on Form 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:
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SOURCE: Nutriband Inc.
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FAQ
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