US FDA Places Mind Medicine Inc.’s (NASDAQ: MNMD) IND Supporting Phase 2 LSD Study On Clinical Hold

Mind Medicine Inc. (NASDAQ: MNMD) has announced that the US FDA has placed a clinical hold on its IND application that intends to support the commencement of a Phase 2b lysergic acid diethylamide (LSD) study for generalized anxiety disorder (GAD) Treatment. The company expects to offer additional information about the decision in the next 30 days.

MindMed is working to deliver LSD to patients 

Chief Executive Officer and Director of the company Robert Barrow said, “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. 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, frequently debilitating mental health illness that affects about 6% of adults in the United States at some point in their lives. According to the National Institute of Mental Health, excessive anxiety and worry that lasts longer than six months can lead to severe impairments in social, vocational, and other functions. Unfortunately, while GAD, Major Depressive Disorder, and other major mental health diseases have a lot of diagnostic overlap, there hasn’t been much innovation in the treatment of GAD in the last few decades.

MindMed meets FDA regarding MindMed Session Monitoring System.

Recently the company met the FDA Centre for Devices and Radiological Health with consultation from the Center for Drug Evaluation and Research regarding various key points for the development of the MindMed Session Monitoring System in a devices pre-submission meeting of October 25, 2021.

The company’s chief medical officer Daniel Karlin stated, “These regulatory engagements provide the opportunity to thoroughly and continually discuss and assess alignment around the various considerations, which are essential to the success and adoption of MindMed’s Session Monitoring System’s regulated components. The FDA is supportive of our plans to develop regulated devices that would allow the use of novel analyses of multimodal data to capture, model, and map outputs.”