SEATTLE–(BUSINESS WIRE)–Receptor Life Sciences (RLS), a clinical-stage pharmaceutical company developing innovative therapies to address central nervous system disorders, announced that the first patient has been dosed in its Phase 1b/2a clinical safety, tolerability, and efficacy study evaluating RLS103 in adult patients with acute anxiety within social anxiety disorder (SAD).
RLS103, a dry powder inhaled cannabidiol (CBD), uses an inhalation formulation technology coupled with a breath-powered device, both currently used in two FDA-approved products. The RLS103 inhalation powder provides IV-like pharmacokinetics and contains synthetic CBD and FDKP, an FDA-approved inhalation excipient.
“Advancing the clinical development of RLS103 and dosing the first patient marks a key milestone for our company,” said Mark Theeuwes, President and CEO of Receptor Life Sciences. “With no acute therapies currently available, RLS103 has the potential to offer immediate relief, in three minutes or less, for patients living with social anxiety. We expect to report topline results by early 2023.”
The Phase 1b/2a clinical trial is a multi-center, randomized, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, and efficacy of two doses of RLS103 in adult subjects with acute anxiety within SAD. The primary endpoint of the study is safety and tolerability. The secondary endpoints are efficacy and changes in physiologic measures of anxiety following a simulated public speaking challenge conducted in a clinical setting. The results from the Phase 1b/2a study will be used to facilitate the design of a larger, well-controlled, randomized safety and efficacy study intended for registration.
According to the Anxiety and Depression Association of America and 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.
About Receptor Life Sciences
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 that hold the potential to provide precision, consistency, reliability, and convenience. For more information about Receptor Life Sciences, its patented product candidates and its progress toward FDA approval, see www.receptorlife.com.