MindMed Shares Update On Phase 2b Trials of LSD For Treating Generalized Anxiety Disorder

MindMed MNMD MMED, a clinical-stage biotech company that is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances, announced on Dec. 21 that the  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, CEO, 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.” 

GAD is a chronic, often debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational, and other functioning, according to the National Institute of Mental Health (NIMH).

According to a press release issued by MindMed, there is substantial diagnostic overlap between GAD, major depressive disorder, and other mental health disorders, while “there has been very little innovation focused on the treatment of GAD in the past several decades.”