Overdose and drug addiction specialist Opiant Pharmaceuticals struck a licensing deal with Sanofi for the development and commercialization of a late-stage-ready treatment for acute cannabinoid overdose.
Southern California-based Opiant, which developed the widely-sued opioid overdose treatment Narcan, plunked down an upfront fee of $500,000 for drinabant, a cannabinoid CB-1 receptor antagonist that will be used in an emergency setting for acute cannabinoid overdose (ACO). The type of overdose that drinabant is being developed for comes from the ingestion of so-called “edibles” that contain large quantities of D9-tetrahydrocannabinol (THC) and synthetic cannabinoids, such as those that are sold with the label K2 or Spice. According to the U.S. Centers for Disease Control and Prevention, synthetic cannabinoids are prepared with various man-made chemicals that can have toxic side effects. These side effects can cause rapid heart rate, vomiting, agitation, confusion, and hallucinations. These synthetic products are typically more potent than marijuana and much less expensive.
Opiant said that synthetic cannabinoids are used to make edible products, such as brownies and cookies. Many people can eat these by accident, which can sometimes result in a toxic reaction that requires a visit to an emergency room. Using 2014 rates from the National Emergency Department sample and United States Census Bureau figures, Opiant estimated that ACO resulted in more than 1 million emergency room visits in 2016. Those rates could rise due to the number of states that have begun to legalize marijuana, Opiant noted.
As of now, there are no treatments for ACO that have been approved by the U.S. Food and Drug Administration. Opiant hopes that drinabant will be the first. The company pointed to early clinical work conducted by Sanofi on drinabant that showed oral administration of the asset was shown to “block both subjective and objective effects of inhaled THC.” However, Opiant said that oral treatment of drinabant has a slow mechanism of action. To rapidly reverse the symptoms of ACO in an emergency room setting, it will require an injectable version, the company said. That Phase I and Phase II clinical work conducted by Sanofi also demonstrated a strong safety profile for drinabant, Opiant said in its announcement.
Opiant Chief Executive Officer Roger Crystal said the deal with Sanofi for drinabant is indicative of the company’s goals to develop best-in-class treatments for addiction and drug overdose.
“We are encouraged by both the safety profile of drinabant, as well as the potential of an injectable CB-1 antagonist to rapidly reverse the symptoms of ACO and address a growing medical need. We intend to initiate development efforts in 2019 and commence clinical studies thereafter,” Crystal said in a statement.
Under terms of the deal, Sanofi will receive $500,000 in an upfront fee from Opiant. The larger pharma company will also be eligible for additional payments based on whether or not Opiant hits certain clinical, regulatory and sales milestones. Opiant will assume all development and commercial responsibilities related to drinabant.