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.
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, coupled with the growing desire that multiple federal agencies including the FDA, have expressed the desire to transition to more abuse-resistant opioid drugs, favorably positions our BIO-MD™ products in the competitive landscape of abuse-resistant opioid products.
The Opioid Epidemic
Pain medications are essential for improving the care and outcomes for the 100 million adults living with chronic pain in the United States. It is estimated that the cost of medical treatment and lost productivity associated with chronic pain is $560-$635 billion annually.
The 300 million pain prescriptions equal a $24 billion worldwide market. America claims less than 5% of the world’s population, yet it consumes roughly 80% of the world’s opioid supply.
However, the abuse and misuse of prescription opioid drugs has reached epidemic proportions in the United States. Despite efforts to develop opioid drug formulations that are resistant to tampering, abusers have matched the advances in pill/tablet formulation technology with new ways to abuse these drugs. Most opioid drugs currently on the market can be physically manipulated (crushed, cut, grated, ground, heated, dissolved) to yield active opioid that can be injected, snorted, smoked, or taken orally.
Increased sales of prescription opioid drugs over the past decade have been matched by a parallel increase in the number of opioid overdose deaths. Deaths related to prescription opioid drugs have increased annually to more than 16,000 in 2010 alone. The Centers for Disease Control and Prevention (CDC) considers the prescription drug abuse crisis in the United States to be an epidemic and the Office of National Drug Control Policy describes it as “the Nation’s fastest-growing drug problem.” In addition to causing health issues, abuse of prescription opioid drugs is associated with high economic costs in both direct health care. and economic impact on the workplace averaging over $72.5 billion annually.
Ensysce has seized on this problem and has developed it highly novel BIO-MD™and MPAR™ pain products. The BIO-MD™, abuse-resistant opioid prodrug technology has the potential to meet the medical needs of patients living with chronic pain, while providing a solution to the national epidemic of prescription opioid abuse.