SEATTLE–(BUSINESS WIRE)–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) has accepted its Investigational New Drug (IND) application for RLS102. This first-in-class, pure synthetic CBD capsule is being investigated for the treatment of irritability in patients with autism spectrum disorder.
RLS102 is a novel formulation that uses an FDA-approved drug delivery technology. Following the IND acceptance, RLS initiated a pharmacokinetic (PK), formulation selection study using RLS102 in healthy volunteers. The results will be used to identify the formulation for clinical development.
The RLS102 capsules contain both pure synthetic cannabidiol (CBD) and SNAC, an FDA-approved oral absorption enhancer. In an initial proof-of-concept clinical study, RLS102 resulted in a 6-fold increase in CBD absorption from the gastrointestinal tract compared to solid oral CBD alone. In addition to improving CBD bioavailability, RLS102 reduces the high variability associated with currently marketed oral CBD products.
“RLS102 has the potential to be a new treatment to reduce irritability in patients living with autism spectrum disorder,” said Mark Theeuwes, President and CEO, Receptor Life Sciences. “This IND acceptance is an important milestone for Receptor Life Sciences and demonstrates our ability to develop drug products in an FDA-regulated environment. We look forward to moving RLS102 into clinical efficacy studies as quickly as possible.”
A complex developmental disorder often associated with a high level of irritability, autism spectrum disorder (ASD) affects about 5 million adults in the United States (https://www.cdc.gov/ncbddd/autism/features/adults-living-with-autism-spectrum-disorder.html). No treatments are approved for adults with ASD-associated irritability.
About Receptor Life Sciences
Receptor Life Sciences is a pharmaceutical company that applies FDA-approved drug delivery technologies to the development of 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.