BIO-MD™ Opioids: Abuse-resistant Opioid Prodrugs

Ensysce Biosciences' proprietary abuse-resistant opioid prodrug technology –                   the BIO-MD™ platform - is designed to improve the care of patients with chronic pain while reducing the human and economic costs associated with prescription opioid drug abuse. Our opioid prodrugs are chemically stable molecules that provide pain relief similar to currently approved opioid drugs. However, unlike commonly used opioid drugs, our prodrugs resist the usual extraction and tampering techniques used by addicts to abuse prescription opioid drugs via injection or snorting, as well as chewing and crushing. Administered intravenously, our opioid prodrugs do not release opioid and do not produce any appreciable opioid effects. Consequently, our opioid prodrugs offer the benefits of effective pain relief with a substantially reduced potential for abuse.

COMMERCIAL OPPORTUNITY

Prescription opioid medications constitute a multi-billion dollar annual market. In 2012, sales of these products were $8.5 billion in the United States and $11.7 billion globally. Annual sales of several extended-release opioid formulations are very robust, including oxycodone ($2.8 billion), oxymorphone ($600 million), morphine ($350 million) and hydromorphone (>$100 million). Effective opioid medications are essential for improving the lives of the 100 million U.S. adults living with chronic pain.

Despite the clear medical need for prescription opioid drugs, the availability of these drugs is associated with a growing epidemic of abuse and misuse. Prescription opioid abuse resulted in more than 16,000 deaths in 2010 in the United States, and the economic impact of prescription drug abuse is $72.5 billion each year in health care costs alone. To address this epidemic, President Obama has called on several federal agencies to expedite the development of abuse-deterrent opioid drugs. The US FDA has committed itself to pushing the US market for opioid drugs in the direction of ever-increasing barriers to abuse and misuse of the prescription drugs.

Several abuse-deterrent opioid products are currently marketed or in late-stage clinical development, but they fall short of being resistant to abuse. Current pill/tablet formulations designed to deter abuse are susceptible to simple extraction techniques and fail to prevent abuse when doses are crushed.

Ensysce Biosciences’ proprietary BIO-MD™ platform effectively resists chewing, crushing, injection, and inhalation; fails to release active opioid when subjected to simple extraction; and resists simple kitchen chemistry approaches that can be used to abuse other unprotected and abuse-resistant opioid pill/tablet formulations. Our technology is broadly applicable to all known opioids, as well as other medications that have the potential for abuse. This higher level of abuse-resistance that our drugs demonstrate, coupled with the growing desire that multiple federal agencies have expressed the desire to transition to more abuse-resistant opioid drugs, favorably positions our opioid prodrugs in the competitive landscape of abuse-resistant opioid products. We believe that novel opioid drug products based on our BIO-MD™ technology will be well positioned to capture significant proportions of their respective markets, creating value for patients, our partners, and our investors