Ensysce Biosciences, Inc. (NASDAQ: ENSC) operates as a clinical-stage biotechnology company, which is focused on leveraging its proprietary technology to develop safer prescription drugs. Shares of the biotech company are rallying 22% through early trading on Tuesday, May 9, 2023. Over the past three months, Ensysce Biosciences has seen an average daily volume of 189,190 shares. However, a volume of 22.35 million shares or dollar volume of around $103.7 million, has already exchanged hands through early trading.

Shares of Ensysce Biosciences are gaining after the company announced it has successfully completed the PF614-MPAR-101 clinical study of their first overdose-protected pain medication, PF614-MPAR. This study involved escalating doses of PF614-MPAR from 25 to 200 mg and demonstrated the drug’s ability to limit opioid delivery when three or more doses are ingested at once.

PF614-MPAR is groundbreaking, being the first drug capable of restricting opioid exposure when an excessive number of pills are consumed, thereby providing an overdose protection mechanism. The clinical study data showed that a 25 mg dose of PF614-MPAR effectively delivered oxycodone as intended for a prescribed dose of one to two capsules. When three or more capsules were administered simultaneously, the amount of opioid released and absorbed into the body was reduced compared to the unprotected PF614, greatly diminishing the risk of overdose.

Opioids are crucial for managing severe pain, such as in patients with cancer or post-operative discomfort, but their use is associated with considerable risk of abuse, addiction, and overdose. Overdoses from opioids are an ongoing issue that can arise from unintentional overuse or deliberate misuse, often when family members find and experiment with these drugs.

Dr. William Schmidt, Ensysce Biosciences’ Chief Medical Officer, expressed that this first-in-human demonstration of the Multi Pill Abuse Resistance (MPAR™) technology’s unique ability to curb the negative impacts of excessive opioid consumption is a significant stride towards the company’s goal of creating safer prescription medications. Pending FDA approval, PF614-MPAR has the potential to revolutionize the treatment of severe pain and provide validation for the wider application of the MPAR™ technology to other drugs.

“This successful outcome brings us closer to the launch of the first opioid with overdose protection,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences. “PF614-MPAR is potentially a first-in-class agent designed to treat severe pain while not only reducing the ability to abuse for recreational purposes but also to provide protection from overdose. The results showed that our patented technology MPAR™, which ‘switches off’ the active drug release, can limit delivery when excess was consumed. Our next step is to clearly define the drug product for all planned dose strengths to optimize effects across our planned dose range. The PF614-MPAR-101 study is particularly important as a proof-of-concept for the base MPAR™ technology which we believe could be used to control delivery of many other drug classes where there may be a narrow therapeutic range. We are excited to explore this further with other therapies as it may help to save many lives in the future

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