Curated News
By: NewsRamp Editorial Staff
September 10, 2025
Nutriband's AVERSA Fentanyl Patch Nears FDA Review with 51% Revenue Surge
TLDR
- 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.
Impact - Why it Matters
This development matters significantly as it addresses the critical need for abuse-deterrent opioid medications amid the ongoing opioid crisis. If approved, AVERSA Fentanyl would represent the first transdermal patch with built-in abuse prevention technology, potentially reducing diversion and misuse while maintaining therapeutic benefits for legitimate pain patients. The simplified regulatory pathway without Phase 2 or 3 trials could accelerate availability of this important safety technology. For investors, the substantial sales projections ($80-200M for fentanyl, $130M for buprenorphine) indicate major market potential in the multi-billion dollar pain management sector, while for healthcare providers and patients, it offers a safer alternative to current opioid delivery systems.
Summary
Nutriband Inc. (NASDAQ: NTRB) has reported impressive financial results for the six months ended July 31, 2025, with revenue surging 50.87% year-over-year to $1.29 million and maintaining robust cash reserves of $6.9 million. The company's strong financial position is fueling the advancement of its groundbreaking AVERSA™ Fentanyl patch, which has a critical Type C FDA meeting scheduled for September 18. This innovative product could become the world's first and only abuse-deterrent transdermal fentanyl patch, with peak annual sales projections ranging between $80 million and $200 million.
The company's development strategy is particularly noteworthy as the New Drug Application (NDA) for AVERSA Fentanyl will rely solely on data from a single Phase 1 Human Abuse Potential study, bypassing the need for Phase 2 or Phase 3 trials. Additionally, Nutriband's second program, AVERSA Buprenorphine, shows significant commercial potential with projected peak annual sales of up to $130 million. The company continues to grow through its Pocono Pharma contract manufacturing subsidiary, which contributed to these record first-half results. For comprehensive details, investors can view the full press release.
Nutriband's proprietary AVERSA™ technology represents a major breakthrough in pharmaceutical safety, designed to be incorporated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. This technology positions the company at the forefront of addressing the ongoing opioid crisis through innovative pharmaceutical solutions. The company maintains an active presence in the investment community through platforms like BioMedWire, which provides specialized communications for the biotechnology and biomedical sectors.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Nutriband's AVERSA Fentanyl Patch Nears FDA Review with 51% Revenue Surge
