Nutriband Soars on Regulatory Path Overview for Transdermal Fentanyl Patch
Shares in Nutriband (Nasdaq: NTRB) climbed nearly 50% in morning trading on Thursday after the company outlined its planned clinical and regulatory path for its lead product, AVERSA™ Fentanyl, an abuse-deterrent fentanyl transdermal patch. Nutriband stated that it will 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.
The company’s NDA application will be based on a single Phase 1 human abuse potential clinical study, which has successfully been completed. AVERSA™ Fentanyl, has the potential to be the first and only abuse deterrent patch approved anywhere in the world.
Nutriband estimates that AVERSA™ Fentanyl has the potential to reach peak annual US sales of between $80 and $200 million, according to a market analysis report from Health Advances. The global opioid market was valued at $22.8 billion in 2022.
Highlights
Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband’s technology into Kindeva’s FDA-approved transdermal fentanyl patch system.
Nutriband’s 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 company’s product development pipeline includes abuse deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate.
The company’s 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.
