We are currently developing drinabant (OPNT004), a high affinity, CB-1 antagonist for the treatment of ACO. The rationale for using drinabant to treat ACO is based on multiple studies demonstrating that CB-1 antagonists like drinabant compete with agonists (THC and SCs) for CB-1 receptors, terminating their pharmacological actions.

The principle of using a competitive receptor antagonist to reverse the pharmacological actions of a drug in an emergency setting has been successful, resulting in multiple FDA approved products, including naloxone to reverse opioid overdose, and flumazenil to reverse benzodiazepine overdose. We believe we can extend this principle to achieve a rapid and effective reversal of ACO in an ED setting.

In clinical studies, drinabant has been shown to be safe and well tolerated for up to 24 weeks following oral administration. However, the slow absorption of oral drinabant is not suitable for producing a rapid reversal of ACO. Thus, we are developing an injectable formulation of drinabant for use in an emergency department setting.

Disease Area

Cannabinoid Overdose

PreclinicalPhase IPhase IIPhase IIINDAFDA Approval
Preclinical
Phase I
Phase II
Phase III
NDA
FDA Approval