Receptor Life Sciences Announces Fda Acceptance Of Ind Application For Rls103 Inhaled Dry Powder Cbd And Initiation Of Ind Opening Clinical Safety And Efficacy Study
Receptor Life Sciences Announces FDA Acceptance of IND Application for RLS103 (Inhaled Dry Powder CBD) and Initiation of IND-Opening Clinical Safety and Efficacy Study
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
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