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.
Nuvalent commences NVL-655 phase 2 clinical trial in subjects with NSCLC and other solid tumours
GC Biopharma's GC1130A receives EMA Orphan Drug Designation
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Newron enrols 290 patients in schizophrenia study
Vistagen granted European patent for AV-101 to treat neuropathic pain
GenSight Biologics reports business and financial update
Alora Pharmaceuticals announces Relexxii commercial launch
IGC Pharma granted patent for Alzheimer's drug formulation
NRx Pharmaceuticals signs data agreement with Columbia University for IV Ketamine trials