Benzinga | Dec 21, 2021 07:32AM EST

MindMed Announces FDA Has Issued A Clinical Hold On Initial IND Submission For Phase 2b Trial Of LSD For Treatment of Generalized Anxiety Disorder

- FDA has issued a clinical hold on initial IND submission required to initiate Phase 2b trial of LSD for the treatment of generalized anxiety disorder -

NEW YORK, Dec. 21, 2021 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (NEO: MMED), (DE: MMQ) (the "Company"), a leading biotech company developing psychedelic-inspired therapies, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its IND submission intended to support the initiation of a Phase 2b trial of lysergic acid diethylamide (LSD) for the treatment of generalized anxiety disorder (GAD). Additional detail regarding the FDA's decision is expected within 30 days.

"Our team has a tremendous sense of urgency to bring new treatments, such as LSD, to the many patients in need, particularly given the growing mental health epidemic," said Robert Barrow, Chief Executive Officer and Director of MindMed. "We remain highly confident in the therapeutic potential of LSD to usher in a new treatment paradigm for these disorders and we look forward to working closely with FDA to satisfy all outstanding concerns as rapidly as possible."