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Reunion Neuroscience Inc. Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of RE104 for the Treatment of Postpartum Depression

Provided By GlobeNewswire

Last update: Sep 18, 2023

WILMINGTON, Del., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2 study of RE104, a novel serotonergic psychedelic compound, for the treatment of postpartum depression (PPD). The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD. The study is expected to begin in Q4 2023 with a targeted data readout in late 2024.

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