Numinus Wellness Comments on FDA Decision on New Drug Application for MDMA-Assisted Therapy for PTSD
"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,"
Spravato® (esketamine) and ketamine continue to be available to practitioners to treat mental health conditions, and
"The FDA decision demonstrates the high level of scrutiny that psychedelic compounds receive and the continuing requirement for comprehensive, rigorous research as some of these investigational products move through late-stage clinical trials," said Dr.
Letter of intent with MedBright AI
Numinus also announces that it has terminated the letter of intent previously announced on
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Forward-looking statements
Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect", and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including the results of further research into MDMA, if any, the FDA and other regulators' decisions in respect of MDMA and other psychedelic medications, restrictions that may be placed on the use of psychedelic compounds by regulatory authorities; safety and efficacy of psychedelic-assisted therapy; acceptance, uptake and commercialization of psychedelic-assisted therapy, if any; dependence on obtaining regulatory approvals, and other risks that are set forth in our annual information form dated
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