The mission to provide safer pain medications is more critical than ever. Ensysce Biosciences, led by Dr. Lynn Kirkpatrick, an expert medicinal chemist and its current CEO, is facing this quest. Xtalks spoke with Dr. Kirkpatrick about Ensysce Biosciences’ innovation in the battle against prescription drug abuse and overdose.
CEO, Ensysce Biosciences
Ensysce Biosciences has a pioneering two-step trypsin activation technology, designed to revolutionize drug delivery across a broad spectrum of medications. This unique approach, involving TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance), ensures that medications are activated only in the small intestine and are resistant to abuse when taken excessively. These technologies have garnered significant recognition, including Fast Track designation for TAAP™ and Breakthrough Therapy designation for MPAR® from the US Food and Drug Administration (FDA), accelerating their potential path to commercialization.
According to the Centers for Disease Control and Prevention (CDC), in 2021, opioids were implicated in 80,411 overdose fatalities, accounting for 75.4 percent of all drug overdose deaths. This public health crisis highlights the urgent need for safer pharmaceutical innovations like those under development by Ensysce Biosciences.
XTALKS CLINICAL EDGE: Issue 2 — Ensysce Biosciences Interview
Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.
A Vision of Safer Medications
Dr. Kirkpatrick begins by outlining the vision that drives Ensysce Biosciences. “Our vision is to provide the most effective drugs with exquisite safety for a number of indications,” she explains. The company’s primary focus is on opioids, a class of drugs where abuse and overdose present significant unmet needs.
Unlike other companies that have traditionally relied on physical barriers in drug formulations to deter abuse, Ensysce Biosciences employs a unique chemical approach. TAAP™ alters the delivery of the drugs to enhance safety and limit abuse methods, while MPAR® adds another layer of overdose protection to TAAP products. This approach, she notes, can provide a more formidable barrier against abuse compared to conventional methods like hard candy shells or gooey gels that have proven ineffective.
Overcoming Challenges with Clever Chemistry
When asked about the biggest challenges the company faces, Dr. Kirkpatrick highlights the complexities of developing drugs in an environment overshadowed by the opioid crisis and resulting regulatory and societal scrutiny.
“We’ve chosen to apply our technology, our clever chemistry, to opioids because of its significant unmet needs,” she states. Despite the obstacles, the company has pressed forward, demonstrating the safety and effectiveness of its products in clinical settings. Their efforts culminated recently in a Breakthrough Therapy designation for their lead product, an indication of their innovative approach to overdose protection.
Strategic collaborations have been vital to Ensysce Biosciences’ development process. Dr. Kirkpatrick emphasizes the importance of partnerships with various external groups that augment her team’s expertise. “We’re a very small team, so we have partners in manufacturing, clinical, regulatory, even financial aspects of the company,” she says. These partnerships have been essential in advancing their R&D goals efficiently.
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