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Investing.com -- Nutriband Inc. (NASDAQ:NTRB) stock surged 8.8% in premarket trading Tuesday following the company’s announcement of a productive meeting with the FDA regarding its lead product, AVERSA™ FENTANYL, an abuse-deterrent fentanyl transdermal system.
The company reported receiving final meeting minutes from its September 18 virtual conference with the FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine. During the meeting, the FDA confirmed the regulatory pathway for the product as a 505(b)(2) New Drug Application and provided guidance on manufacturing process validation, product specifications, and stability testing plans.
The FDA also offered feedback on planned laboratory studies to characterize the product’s abuse-deterrent properties. The agency acknowledged that fentanyl patch abuse, misuse, and accidental exposure remain important issues to address and offered ongoing support throughout the development program.
"We are thankful for the opportunity to discuss the CMC aspects of our abuse deterrent fentanyl patch with the Agency. We are excited to incorporate the advice and constructive feedback that we received from the FDA into our development program as we move towards an IND filing in support of a Human Abuse Potential clinical study," said Alan Smith, Ph.D., Chief Operating Officer of Nutriband and President of its 4P Therapeutics subsidiary.
Nutriband is developing the product in partnership with Kindeva, combining Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. The company estimates AVERSA™ FENTANYL could potentially reach peak annual US sales of $80 million to $200 million.
The product aims to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential while ensuring accessibility for patients who need them. If approved, it could become the first abuse-deterrent fentanyl patch worldwide.
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