Receptor Life Sciences (RLS), a pharmaceutical company developing innovative therapies to address central nervous system disorders, announced the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for RLS103. RLS103, a dry powder inhaled cannabidiol (CBD), is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder.
RLS103 uses a drug delivery technology comprising a proprietary CBD inhalation powder and a breath-powered device used in an FDA-approved product. RLS is initiating a proof-of-concept Phase 1b clinical safety and efficacy study in social anxiety disorder. The results will be used to facilitate the design of a larger, well-controlled, randomized Phase 2/3 safety and efficacy study intended for registration.
The RLS103 inhalation powder contains synthetic CBD and FDKP, an FDA-approved inhalation excipient. In an initial proof-of-concept pharmacokinetic clinical study, RLS103 provided immediate CBD absorption with peak concentration less than 4 minutes after inhalation. Compared to oral CBD (Epidiolex oral solution), bioavailability was 9-fold higher, and peak concentrations were 71-fold higher following RLS103 inhalation according to data published in the Journal of Pharmaceutical Sciences. Additionally, first-pass hepatic metabolites were essentially absent. This observation is directly opposite to that seen after oral CBD administration, where circulating hepatic metabolites are about 10-fold higher than circulating CBD.
“No currently available therapies address the challenge of providing immediate relief for patients living with social anxiety,” said Mark Theeuwes, President and CEO, Receptor Life Sciences. “This IND acceptance allows us to test RLS103 in a number of clinical proof-of-concept safety and efficacy studies. The results will guide continued development in indications that show the most promise. RLS103 has the potential to be the first-in-class treatment for acute anxiety disorders.”
According to the Anxiety and Depression Society of America, panic disorder affects about 5.4 million adults in the United States, according to the National Institute of Mental Health. Social Anxiety Disorder affects about 15 million adults in the U.S. and is the second-most commonly diagnosed anxiety disorder.