(La Jolla, CA USA) The world is experiencing a crisis in prescription drug abuse and overdose.
(La Jolla, CA USA) The world is experiencing a crisis in prescription drug abuse and overdose. According to the NIH (National Institutes of Health), several types of prescription medications are commonly abused by patients, including opioids, central nervous system (CNS) depressants like those used for anxiety and sleep problems, and stimulants, for problems like ADHD. Some over-the-counter (OTC) medicines can also be abused when not taken as directed.
Until now, the medical community has endeavored to battle the prescription drug crisis through a variety of means including designing Abuse Deterrent Formulations (ADF’s), prescribing lower concentration dosages, prescribing drugs to be taken less frequently and other measures. As is evidenced by numbers that continue to reflect growing prescription drug abuse over the last decade and more, none of these measures has worked to curb misuse.
Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, believes her company has developed novel technologies that have the potential to stem the prescription drug abuse crisis.
Says Kirkpatrick, “Ensysce’s chemical prodrug drug delivery solutions can be applied to a major of proprietary and generic drugs worldwide.”
One example, based upon Kirkpatrick’s company’s unique approach and the unmet need in the opioid space, has already been awarded “Fast Track” designation by the FDA, designed to accelerate clinical development of novel therapies through to commercialization. That drug, called PF614, is Ensysce’s answer for treating severe and chronic pain. It is a novel proprietary chemically modified oxycodone prodrug, currently in Phase 2 clinical trials. PF614 is only active if taken orally and is designed to reduce all non-oral routes of use, while providing pain relief equivalent to oxycodone. PF614 is tamper-resistant because it only becomes active when swallowed and exposed to naturally occurring Trypsin, an enzyme in the gut. Importantly, an added layer of protection can be added to the Trypsin Activated Abuse Protection (TAAP™) platform applied to PF614. This second layer of protection involves combining a trypsin inhibitor to TAAP prodrugs so that the trypsin activation is shut down when too many pills are swallowed, preventing overdose. This Multi-Pill Abuse Resistance (MPAR™) platform, is being applied to PF614 and can be applied to all TAAP™ prescription drugs. PF614-MPAR is also now being studied in a clinical setting.
Although Ensysce’s PF614 is progressing well through its clinical development and Kirkpatrick believes that the company can contribute to advancements in drug delivery by working with other companies who may benefit by using TAAP technology. Ensysce technology could enhance orally delivered drugs requiring frequent injections or to improve delivery through the gastrointestinal tract. She says, “With TAAP™ making oral delivery feasible, as well as allowing control of the release rate, it may improve patients’ compliance and result in an improved quality of life.”
Kirkpatrick observes, “Pharmaceutical companies want to provide the best options for their patients, so if our TAAP technology can improve the properties of therapeutics in other areas, collaboration makes sense. For companies working to reinvent, revitalize, or develop novel therapies, collaboration can maximize product value and foster drug innovation.”
Dr. Kirkpatrick says, “We are on the cusp of a completely new paradigm for delivery of prescription medicines, one with the potential to provide improved therapeutic outcomes.”
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About Ensysce Biosciences
Ensysce Biosciences (NASDAQ: ENSC), San Diego, CA is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is in the process of developing a new class of powerful, tamper-proof opioids that prevent both drug abuse and overdoses. Ensysce’s products are anticipated to provide safer options to treat severe pain and assist in preventing deaths caused by opioid abuse, reducing the human and economic cost. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
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