VANCOUVER, BC , Aug. 12, 2024 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF ), a leader in mental health care specializing in innovative and evidence-based treatments, comments on the U.
S. Food and Drug Administration's ("FDA") decision to not approve Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with post-traumatic stress disorder ("PTSD"). According to a news release issued by Lykos Therapeutics, the FDA has requested that an additional Phase 3 study be conducted to study the safety and efficacy of MDMA further.
"While this is a blow to all the incredibly positive and encouraging work that has been done to advance safe access to psychedelic therapy, which MAPS and Lykos have led the charge for, we remain unwavering and committed to doing all we can to make these important therapies available for all those suffering who need it most," said Payton Nyquvest, Numinus Founder and CEO. "We're confident that further study will continue to show the efficacy of MDMA, and with many psychedelic compounds at the late stages of research, the pipeline of treatments to address severe conditions remains strong." "For Numinus, we will continue to execute on our previously announced plan to achieve profitability with our existing operations, which were and continue not to be dependent on the commercialization of new therapies," Mr.
Nyquvest added. Sp.