Anebulo wins positive FDA feedback to Advance phase 3 program for cannabis

[Lifeking/Adobe Stock]

The clinical stage biopharma Anebulo Pharmaceuticals recently shared that it received positive FDA feedback after a Type B meeting in July, where the regulatory agency indicated a path to approval for ANEB-001, a competitive CB1 antagonist with a high affinity for the human CB1 receptor. Overstimulation of this receptor by cannabinoids such as THC causes the psychoactive effects of cannabis. ANEB-001 seeks to counter these effects in acute cannabinoid intoxication (ACI) by inhibiting the receptor’s activation.

The FDA indicated that a study of the cannabinoid antagonist ANEB-001 in ACI patients presenting to emergency departments together with a larger THC challenge study could support a new drug application.

ANEB-001 is Anebulo’s lead product candidate.

The company recently wrapped up an open-label part C extension of its phase 2 clinical trial to investigate ANE…

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