Nutriband Reports 51% Revenue Growth, Advances Abuse-Deterrent Fentanyl Patch Toward FDA Review

By Advos

TL;DR

Nutriband's AVERSA Fentanyl could capture a first-mover advantage with estimated peak annual sales up to $200 million if approved.

Nutriband's NDA for AVERSA Fentanyl relies solely on Phase 1 data with no Phase 2 or 3 trials required for FDA approval.

AVERSA technology prevents abuse of potent drugs, making transdermal patches safer for patients and reducing diversion risks in communities.

Nutriband's revenue grew over 50% year-over-year while developing the world's first abuse-deterrent fentanyl patch using innovative AVERSA technology.

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Nutriband Reports 51% Revenue Growth, Advances Abuse-Deterrent Fentanyl Patch Toward FDA Review

Nutriband Inc. (NASDAQ: NTRB) reported significant financial progress with revenue reaching $1.29 million for the six months ended July 31, 2025, representing a 50.87% year-over-year increase. The company maintains a strong cash position of $6.9 million, which it states will support the advancement of its lead product candidate, AVERSA Fentanyl.

The company has scheduled a Type C meeting with the U.S. Food and Drug Administration for September 18 to discuss the regulatory pathway for AVERSA Fentanyl. Notably, Nutriband emphasized that its New Drug Application will rely on data from a single Phase 1 Human Abuse Potential study, with no Phase 2 or Phase 3 clinical trials required. This streamlined development approach could accelerate the product's path to market.

If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal fentanyl product globally. The company projects peak annual sales between $80 million and $200 million for this product. Additionally, Nutriband's second program, AVERSA Buprenorphine, is projected to reach peak annual sales of up to $130 million.

The revenue growth was supported by the company's contract manufacturing subsidiary, Pocono Pharma, which contributed to record first-half performance. More information about the company's financial results can be found in their full press release at https://ibn.fm/spHiy.

The development of abuse-deterrent fentanyl technology addresses a critical public health need amid the ongoing opioid crisis. Transdermal fentanyl patches have been subject to abuse through methods such as extraction and injection, leading to serious health consequences including overdose deaths. AVERSA technology, which can be incorporated into any transdermal patch, is designed to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

For investors seeking additional information, the company maintains a newsroom at https://ibn.fm/NTRB where updates relating to NTRB are available. The successful development and potential approval of AVERSA Fentanyl could position Nutriband as a significant player in the abuse-deterrent pharmaceutical market while addressing an important public health challenge.

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