Nutriband receives notice of allowance for U.S. trademark for AVERSA

Nutribandreceived a Notice of Allowance from the United States Patent and Trademark Office on July 9, 2024, for trademark application Serial Number 98117984, covering the mark “AVERSA.” The Notice of Allowance signifies that the USPTO is expected to grant a trademark registration for this application following the completion of administrative processes. The AVERSA trademark is integral to Nutriband’s platform technology which can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is AVERSA Fentanyl, an abuse deterrent fentanyl transdermal system. Nutriband, in partnership with Kindeva Drug Delivery, is progressing towards completing the scale-up of the commercial manufacturing process for AVERSA Fentanyl. This partnership has successfully moved from a feasibility agreement to a commercial development and clinical supply agreement aimed at manufacturing product for the upcoming human abuse potential clinical study. This study is crucial for the New Drug Application that Nutriband plans to submit to the FDA. Upon completion of the commercial manufacturing process, Nutriband will file an Investigational New Drug application with the FDA. This filing will precede the pivotal laboratory and clinical evaluations needed to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in line with FDA Guidance. The IND will include comprehensive chemistry, manufacturing, and controls information and the clinical study protocol for the human abuse potential study. The pivotal clinical study will involve a randomized, double-blind, placebo-controlled, and positive-controlled crossover design, comparing AVERSA Fentanyl to a currently marketed fentanyl patch without abuse-deterrent technology. This human abuse potential study will assess the drug’s “liking” among recreational users, which is predictive of the likelihood of abuse. Preliminary studies have shown that AVERSA technology is highly resistant to physical and chemical manipulation, reinforcing its potential effectiveness as an abuse deterrent.