SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC) has received guidance from the Food and Drug Administration (FDA) on its non-clinical program for PF614-MPAR, a 'Next Generation' opioid analgesic designed to treat severe pain with built-in overdose protection. This feedback is a step toward a New Drug Application (NDA) for the product, which incorporates both a trypsin-activated abuse protection (TAAP) oxycodone prodrug and a trypsin inhibitor for overdose prevention.
The company's lead drug candidate, PF614, has recently entered Phase 3 clinical development after showing efficacy and safety in trials. PF614-MPAR builds on this by adding nafamostat, which inhibits the release of oxycodone when excessive doses are taken. This innovative safety feature is a first in the opioid market, aiming to address the persistent issue of prescription opioid overdose.
Ensysce's CEO, Dr. Lynn Kirkpatrick, expressed gratitude for the FDA's guidance and highlighted the significance of PF614-MPAR's Breakthrough Therapy designation, which was previously granted by the FDA. This status facilitates more frequent consultations with FDA experts, potentially expediting the development process.
The company is focused on developing safer prescription drugs using its proprietary TAAP and Multi-Pill Abuse Resistance (MPAR) platforms. These technologies aim to minimize risks associated with drug abuse and accidental overdose, providing safer treatment options for severe pain and contributing to the reduction of medication abuse-related deaths.
Ensysce's efforts come at a critical time as opioid overdose continues to be a major public health concern in the United States. The company's approach to improve therapeutic outcomes and reduce abuse could potentially benefit both new and existing drugs.
The information for this article is based on a press release statement. Ensysce's product candidates, including PF614-MPAR, are still in clinical development and have not yet been approved. There is no guarantee of successful outcomes in the ongoing trials or future regulatory approvals. Ensysce's forward-looking statements are subject to risks and uncertainties that could affect the actual results, performance, or achievements of the company.
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