Receptor Life Sciences (RLS) has published data from a Phase 1 PK trial of its RLS103 dry powder cannabidiol (CBD) in the Journal of Pharmaceutical Sciences demonstrating significantly greater bioavailability for the inhaled CBD than for Epidiolex oral CBD solution. RLS announced completion of its pre-IND meeting with the FDA in January 2021.
Receptor licensed MannKind Corporation’s Technosphere dry powder technology for use with its cannabinoid products in 2016. The company is developing the DPI for the treatment of performance anxiety in patients with social anxiety disorder and for the treatment of panic disorder.
The study enrolled 23 subjects who received either a single 50 mg dose of Epidiolex or 10 mg of the dry powder formulation delivered via the Dreamboat inhaler (2.1 mg CBD in delivered dose). Dose-adjusted Cmax for the inhaled CBD formulation was 71-fold greater than for the oral solution, and overall exposure was 9 times higher for the inhaled CBD. The mean Tmax was approximately 122 minutes for the oral CBD and just under 4 minutes for the inhaled CBD group.
Receptor Life Sciences Chief Scientific Officer Andrea Leone-Bay commented, “Based on the PK profile, RLS103 has the potential to be the first-in-class immediate-acting CBD product for time-of-need indications like performance anxiety and acute panic. Currently, there are no FDA approved treatment options available for these patients.”
Read the Receptor Life Sciences press release.
Read the Journal of Pharmaceutical Sciences article.
