Cannabidiol Technosphere (cannabidiol inhalation powder) / Receptor Life Sci - LARVOL DELTA

Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder. (PubMed, AAPS J) - "In conclusion, this study successfully develops a cannabidiol inhalation powder by particle engineering having suitable aerosolization behavior...It has been shown that active molecules that are only slightly soluble in water can be formulated effectively as a powder for inhalation. Other molecules could be tested and subsequent in vivo studies conducted to demonstrate correlation with these in vitro results."

Journal • Oncology

Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Receptor Life Sciences | Phase classification: P1b ➔ P1 | Trial completion date: Jul 2023 ➔ Feb 2024 | Not yet recruiting ➔ Terminated | Trial primary completion date: Jul 2023 ➔ Feb 2024; Lack of enrollment

Phase classification • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Epilepsy

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD) (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Receptor Life Sciences | Phase classification: P1b/2a ➔ P1 | N=40 ➔ 0 | Completed ➔ Withdrawn

Enrollment change • Phase classification • Trial withdrawal • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD) (clinicaltrials.gov) - P1b/2a | N=40 | Completed | Sponsor: Receptor Life Sciences | Recruiting ➔ Completed | N=30 ➔ 40 | Trial completion date: Mar 2023 ➔ Nov 2022 | Trial primary completion date: Mar 2023 ➔ Nov 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy (clinicaltrials.gov) - P1b | N=5 | Not yet recruiting | Sponsor: Receptor Life Sciences

New P1 trial • CNS Disorders • Epilepsy

Receptor Life Sciences Opens Second Investigational New Drug (IND) Application with FDA for RLS103 (Inhaled Dry Powder CBD) for the Treatment of Rapid Epileptic Seizure Termination (REST) (Businesswire) - "Receptor Life Sciences (RLS)...is expanding the potential clinical utility of RLS103 into epilepsy. A proof-of-concept clinical safety and efficacy study in epilepsy will be conducted under a second, recently opened IND application. The Phase 1b randomized, double-blind, placebo-controlled, crossover study will evaluate RLS103 in patients with photosensitive epilepsy as a model for REST. RLS103, a dry powder inhaled cannabidiol (CBD), is a first-in-class drug/device combination product for the acute treatment of psychiatric and neurological disorders. Epilepsy study startup is underway."

IND • CNS Disorders • Epilepsy

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 (Businesswire) - "Receptor Life Sciences...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....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. 'This IND acceptance allows us to test RLS103 in a number of clinical proof-of-concept safety and efficacy studies. The results will guide continued development in indications that show the most promise. RLS103 has the potential to be the first-in-class treatment for acute anxiety disorders.'"

IND • New P1 trial • CNS Disorders • Social Anxiety Disorder