Ensysce Biosciences Hits Major Milestone in Opioid Use Disorder Program

Ensysce Biosciences, a clinical-stage pharmaceutical company focused on developing innovative solutions to alleviate severe pain while minimizing opioid misuse and overdose, has announced a significant advancement in its opioid use disorder (OUD) program. The company has selected its lead drug candidate, PF9001, to proceed into Investigational New Drug (IND) enabling studies.

PF9001 is designed using Ensysce's cutting-edge Trypsin Activated Abuse Protection (TAAP) platform, which aims to reduce the potential for abuse. One of the notable benefits of PF9001 is its lower likelihood of causing cardiovascular side effects compared to traditional OUD treatments like methadone. This advancement has been financially supported by a multi-year Helping to End Addiction Long-Term (HEAL) award, amounting to up to $15 million, provided by the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA).

Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed enthusiasm about the milestone, stating, "The adaptability of our TAAP technology platform has shown benefits in therapeutic areas beyond pain and ADHD. Our unique approach, which allows us to control drug activity through trypsin activation, presents a significant advantage for new drug development. As we integrate OUD into our product pipeline, we anticipate advancing PF9001 to human clinical trials within the next 12 to 18 months. The considerable funding from the NIDA and HEAL program, focused on curtailing drug abuse and addiction, has been crucial in reaching this milestone, and we are grateful for their continued support."

About Ensysce Biosciences

Ensysce Biosciences is dedicated to creating safer prescription medications using its proprietary technology platforms. The company leverages its Trypsin Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms to develop unique, tamper-proof treatments for severe pain that significantly reduce the risk of drug abuse and overdose. Ensysce's anticipated products aim to offer safer options for patients dealing with severe pain and help prevent fatalities due to medication abuse. The company's technological innovations are covered by an extensive global intellectual property portfolio, encompassing a wide range of prescription drug compositions.

Ensysce's focus on developing safer opioid alternatives is particularly pertinent in the context of the ongoing opioid crisis, which has resulted in widespread addiction and numerous overdose deaths. The company’s TAAP and MPAR platforms represent a promising approach to addressing these issues by creating medications that are resistant to common methods of abuse, such as crushing or dissolving pills for inhalation or injection.

In summary, Ensysce Biosciences is making significant strides in the field of opioid use disorder treatment with the selection of its lead candidate, PF9001, for further development. Supported by substantial funding from the NIH and NIDA, the company aims to bring this innovative treatment to clinical trials in the near future, potentially offering a safer alternative to existing OUD therapies.

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