Nutriband Secures FDA Engagement for Abuse-Deterrent Fentanyl Patch Development
TL;DR
Nutriband's FDA approval for AVERSA Fentanyl technology provides a competitive edge in addressing unmet medical needs through novel abuse-deterrent transdermal patches.
The FDA Type C Meeting on September 18 focuses on Nutriband's CMC plans for AVERSA Fentanyl development using the 505(b)(2) regulatory pathway.
Nutriband's abuse-deterrent fentanyl patch technology enhances patient safety by preventing misuse and accidental exposure to potent medications.
Nutriband's AVERSA technology transforms transdermal patches into abuse-resistant systems leveraging existing drug safety data for faster regulatory approval.
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Nutriband Inc. (NASDAQ: NTRB) has achieved a critical regulatory milestone with FDA approval for a Type C meeting regarding its AVERSA™ abuse-deterrent technology for fentanyl transdermal patches. The scheduled September 18 meeting with the FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine will focus on comprehensive Chemistry, Manufacturing, and Controls plans covering the entire development and commercialization timeline.
This FDA engagement represents formal agency recognition of AVERSA™ technology's potential to address critical unmet medical needs in opioid abuse prevention. The meeting approval signals that regulators view Nutriband's approach as having significant promise in combating the ongoing opioid crisis. The development pathway addresses the complete arc from Investigational New Drug submission through 505(b)(2) New Drug Application approval.
The 505(b)(2) regulatory pathway allows Nutriband to leverage existing fentanyl safety data while focusing regulatory review specifically on the novel abuse-deterrent components of its technology. This streamlined approach could potentially accelerate the development timeline compared to traditional drug approval processes. AVERSA technology is designed to be incorporated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
For more information about Nutriband's technology and development programs, visit https://www.Nutriband.com. Additional news and updates relating to NTRB are available through the company's newsroom at https://ibn.fm/NTRB.
The advancement of abuse-deterrent technologies represents a crucial front in the battle against opioid addiction and overdose deaths. Successful development of effective abuse-deterrent formulations could significantly impact public health by reducing the potential for prescription opioid misuse while maintaining legitimate medical access for patients suffering from chronic pain. This regulatory progress demonstrates the pharmaceutical industry's ongoing commitment to addressing the opioid crisis through innovative technological solutions.
Curated from InvestorBrandNetwork (IBN)
