Sanofi has outlicensed global development and commercialization rights to drinabant to Opiant Pharmaceuticals, which said yesterday it plans to start developing the acute cannabinoid overdose (ACO) candidate in the new year.
Drinabant (once known as AVE-1625) is a cannabinoid CB-1 receptor antagonist that Opiant said will be developed as an injectable for administration in an emergency department setting.
Oral drinabant is slower than needed for emergency situations, hence the need for an injectable form, Opiant said. Those situations are expected to increase along with incidents of ACO as a growing number of states legalize marijuana for personal and recreational use, Opiant reasons, creating demand that the company aims to satisfy with drinabant.
ACO is most often linked to ingestion of edibles and synthetic cannabinoids; its symptoms can include panic and anxiety, feelings of paranoia, agitation, visual and auditory hallucinations, and nausea. Opiant cited a 2015 study published in Journal of Psychopharmacology which reported that symptoms of ACO often require emergency medical attention and can take six or more hours to resolve.
“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,” Opiant CEO Roger Crystal, M.D., said in a statement. “We intend to initiate development efforts in 2019 and commence clinical studies thereafter.”
Sanofi previously sought to develop drinabant as an oral drug. Opiant cited a clinical trial by Sanofi and the Centre for Human Drug Research, in which oral drinabant blocked both subjective and objective effects of inhaled THC—one of multiple Phase I and II studies of the drug conducted in an earlier Sanofi clinical program.
Those studies include a terminated Phase II trial (NCT00439634) designed to assess drinabant’s efficacy against cognitive impairment in patients diagnosed with schizophrenia based on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive battery. The trial was terminated in 2016 following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy, Sanofi disclosed on Clinicaltrials.gov.
In the partnership with Sanofi, Opiant has agreed to assume all development and commercial responsibilities related to drinabant.
Opiant said it agreed to pay Sanofi $500,000 upfront, and undisclosed additional payments tied to achieving clinical, regulatory, and sales milestones.
Opiant developed Narcan® Nasal Spray (naloxone HCl), an opioid overdose reversal treatment marketed by commercial partner Adapt Pharma. Narcan won FDA approval in November 2015.