FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed
NEW YORK and MELBOURNE, Australia, Aug. 05, 2024 (GLOBE NEWSWIRE) — Incannex Healthcare Inc. (Nasdaq:IXHL), (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA’) to conduct the Company’s Investigational New Drug (‘IND’) opening Phase 2 clinical trial. The trial will investigate Incannex’s psilocybin pharmaceutical formulation, known as PSX-001, in conjunction with psychotherapy in patients with generalised anxiety disorder in the United States and the United Kingdom.