Numinus Wellness’ Response to FDA’s MDMA Decision

Numinus Wellness Inc (TSX:NUMI), a mental health care specializing in innovative treatments, recently commented on the FDA’s decision regarding Lykos Therapeutics’ new drug application for MDMA for individuals with PTSD. The FDA’s request for an additional Phase 3 study poses a setback in advancing safe access to psychedelic therapy. However, Numinus will aim to make these therapies available for those in need.

Payton Nyquvest, Numinus Founder and CEO, expressed confidence in the efficacy of MDMA and the ongoing research in the psychedelic field. Despite this regulatory hurdle, he outlined that the company will continue to be dedicated to its mission and plans to achieve profitability through existing operations, independent of new therapy commercialization.

Numinus continues to offer Spravato® (esketamine) and ketamine treatments, with over 43,600 administered at its clinics. The company aims to expand its offerings to mental health professionals nationwide. Through Cedar Clinical Research, Numinus has conducted studies on psychedelic medicines involving more than 50 subjects, while its practitioner training program prepares teams to administer various medications and modalities.

Dr. Paul Theilking, Numinus Chief Science and Medical Officer, highlighted the research required for psychedelic compounds and emphasized the company’s commitment to clinical trials and research partnerships in advancing these treatments.

However moving forward, Numinus faces challenges that will require urgent attention to ensure its operational sustainability and growth. Outside of the FDA’s decision on MDMA, Numinus will need to diversify their service offerings by expanding patient reach, which will be vital for them to maintain market presence and financial stability.