The FDA provided positive feedback to Anebulo Pharmaceuticals (NASDAQ:ANEB) for its Phase 3 program of ANEB-001 in patients suffering from acute cannabinoid intoxication (ACI) and substance abuse.
The FDA indicated that a single well-controlled study of ANEB-001 in ACI patients presenting to the emergency department combined with a larger THC challenge study in volunteers could potentially provide substantial evidence to support a new drug application.
“Based on this constructive guidance and continuing dialog with the FDA, we are focusing on finalizing our registrational study designs,” Simon Allen, CEO of Anebulo, said in a statement.
In addition to receiving the final minutes of the FDA meeting, Anebulo also completed dosing in an open-label Part C extension of its Phase 2 clinical trial to evaluate the safety and efficacy of ANEB-001 at higher challenge doses of THC.
