Numinus CEO Payton Nyquvest Believes MDMA "Most Likely" To Be Approved At The End Of 2023

Following recent fourth quarter financial results, Numinus Wellness Inc. NUMIF CEO Payton Nyquvest gave his views on Numinus’ first quarterly earnings report following the consolidation of Novamind Inc., and the roadmap for profitability now that its U.S. footprint has been established within the context of a favorable regulatory outlook.

One projected avenue for growth resides in an expanding clinic diversification towards adjacent psychedelic compounds. In the U.S., ketamine is currently the most common drug administration alongside assisted therapy, however, there is promise that regulatory approval for 3,4-methylenedioxy-methamphetamine—otherwise known as MDMA—is forthcoming in 2023.

MDMA is a synthetic drug that alters mood and perception—specifically awareness of surrounding objects and conditions. It is chemically similar to both stimulants and hallucinogens, producing feelings of increased energy, pleasure, emotional warmth, and distorted sensory and time perception. Its effects usually last between 3 to 6 hours, compounding in a dose-dependent manner.

MDMA increases the availability of serotonin—a key player in all hallucinogenic drugs—accounting for its users’ increased sensitivity to music and preceptory senses. Its stimulation of norepinephrine and dopamine release may explain the euphoria and increased energy users experience, and increased cortisol levels are implicated in decreasing fatigue.

In terms of timelines for approval for MDMA in a clinical setting, Payton Nyquvest believes regulators will act as soon. With the drug showing profound positive effects in clinical trials and an excellent safety profile, patients may have access to a new weapon to combat depression as soon as next year:

"Next year is really kind of prime time, right? You have MDMA most likely being approved towards the end of next year. You have all of the regulatory changes happening at the state level. So I think, it’s… really for us, we’ve positioned ourselves, again, where we’ve always wanted to be that service provider of choice."

Payton’s comments are not alone in isolation. Recently, Kelan Thomas, PharmD, MS, associate professor of clinical sciences at Touro University California College of Pharmacy told the Pharmacy Times that “it seems like by about the end of 2023, MDMA is very likely to become FDA-approved for PTSD” with psilocybin to follow the year after.

In 2021, MDMA research picked up considerable attention when results of the first Phase 3 trial of MDMA-assisted therapy for PTSD, published on May 10, 2021 in Nature Medicine, revealed statistically significant data. A full 88% of study participants responded postiviely to the treatment, and the drug demonstrated a favorable safety profile.

A subsequent blinded interim analysis of MAPP2 results (as of May 2022), conducted by an independent Data Monitoring Committee, indicated that the trial had a sufficient number of participants, and had at least a 90% probability of obtaining statistical significance.

This article was originally published on The Dales Report and appears here with permission.