FDA to meet with Nutriband on abuse-deterrent fentanyl patch

ORLANDO - The U.S. Food and Drug Administration has granted a Type C Meeting to Nutriband Inc. (NASDAQ:NTRB), a pharmaceutical company whose stock has surged over 50% year-to-date, to discuss its AVERSA FENTANYL abuse-deterrent transdermal system, according to a press release statement issued Friday. InvestingPro data shows the company maintains strong liquidity with a current ratio of 3.7x, despite operating in pre-profit stage.

The virtual meeting, scheduled for September 18, 2025, will focus on providing feedback on the Chemistry, Manufacturing, and Controls plans for the product from initial application through potential commercialization.

Nutriband is developing the product in partnership with Kindeva, combining Nutriband’s AVERSA abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. The technology incorporates aversive agents into transdermal patches designed to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.

The company describes AVERSA FENTANYL as potentially becoming the first abuse-deterrent opioid patch of its kind. The technology has received patent protection in 46 countries including the United States, Europe, Japan, and China.

Fentanyl, a powerful synthetic opioid, is commonly prescribed in patch form for severe pain management but has been subject to misuse and diversion. Nutriband’s technology aims to maintain accessibility for patients who need the medication while deterring potential abuse.

The meeting will be held with the FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine in the Office of Neuroscience, Center for Drug Evaluation and Research.

In other recent news, Nutriband Inc. has announced a 25% preferred stock dividend for its shareholders. Investors holding shares as of the July 25, 2025, record date will receive one preferred share for every four common shares owned, with the distribution scheduled for August 5. The preferred shares are convertible to common shares following FDA approval of Nutriband’s AVERSA Fentanyl product. Additionally, the company’s board of directors has approved an amendment to authorize a new class of non-voting Series A Convertible Preferred Stock, allowing for the issuance of up to 2,788,678 shares. This amendment was approved on July 9 and includes a par value of $0.001 per share. In a separate development, Nutriband has secured a U.S. patent for its AVERSA™ abuse deterrent technology. This patent, issued on June 3, 2025, enhances Nutriband’s intellectual property rights and complements its existing portfolio in 46 countries.

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