Numinus Wellness Responds to FDA Decision on MDMA-Assisted Therapy for PTSD

Vancouver, BC, Aug. 12, 2024 - Numinus Wellness Inc. ("Numinus"), known for its pioneering work in mental health care and evidence-based treatments, has provided commentary on the recent U.S. Food and Drug Administration (FDA) decision regarding Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules). This application was intended for use with psychological intervention in patients suffering from post-traumatic stress disorder (PTSD). The FDA has requested an additional Phase 3 study to further investigate the safety and efficacy of MDMA.

Payton Nyquvest, Founder and CEO of Numinus, expressed his disappointment but remained hopeful. He acknowledged the setback but emphasized the company's ongoing commitment to making innovative therapies available to those in need. Nyquvest is optimistic that further research will affirm MDMA's efficacy and highlighted the robust pipeline of psychedelic treatments nearing the final stages of research.

Despite this development, Numinus continues to focus on its existing operations and aims to achieve profitability independently of new therapy commercialization. The company offers treatments using Spravato® (esketamine) and ketamine, having delivered over 43,600 such treatments through its clinics. Numinus has established a successful business model, featuring top-tier patient care and expertise in reimbursed billing, and aims to expand its reach across the U.S.

Through Cedar Clinical Research, Numinus has been involved in studies of four psychedelic medicines over the last two and a half years, treating over 50 subjects. The company’s practitioner training program equips the Numinus team and trainees with the skills to treat patients using various medications and modalities, including MDMA and ketamine.

Dr. Paul Theilking, Chief Science and Medical Officer of Numinus, pointed out that the FDA's decision underscores the rigorous scrutiny psychedelic compounds undergo. He emphasized the necessity for thorough research as these compounds move through late-stage clinical trials. Dr. Theilking affirmed the company's pride in its clinical trials and its dedication to being a research partner as more psychedelic treatments are developed.

Numinus also announced the termination of its letter of intent to acquire MedBright AI Investments Inc., which was initially revealed on June 20, 2024.

Numinus Wellness Inc. (TSX: NUMI), is focused on innovative mental health care and the delivery of safe, evidence-based psychedelic-assisted therapies. Their model aims to treat the root causes of mental health issues such as depression, anxiety, trauma, pain, and substance use, rather than merely managing symptoms. Numinus is at the forefront of integrating these therapies into mainstream clinical practice, contributing to a healthier society.