Therapy Areas: Central Nervous System
Receptor Life Sciences Receives FDA Acceptance of IND Application for RLS103 (Inhaled Dry Powder CBD) and Initiation of IND-Opening Clinical Safety and Efficacy Study
30 March 2022 - - The US Food and Drug Administration accepted US-based pharmaceutical company Receptor Life Sciences' Investigational New Drug application for RLS103. RLS103, a dry powder inhaled cannabidiol, is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder, the company said.

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 four 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.

According to the Anxiety and Depression Society of America, panic disorder affects about 5.4m adults in the United States, according to the National Institute of Mental Health. Social Anxiety Disorder affects about 15 m adults in the US and is the second-most commonly diagnosed anxiety disorder.

Receptor Life Sciences is a pharmaceutical company that applies FDA-approved drug delivery technologies to develop innovative therapies to address central nervous system disorders that have few safe and effective treatments.

Receptor Life Sciences uses these technologies to produce inhaled and oral cannabinoid products.
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