Companies look to psychedelics as treatment for mental health disorders

Photo: Colorful psychedelic collage with mushrooms, medicines and flowers/Courtesy © Nicole Bean

Photo: Colorful psychedelic collage with mushrooms, medicines and flowers/ © Nicole Bean

The next few years could see a major shift in the US government’s approach to regulating psychedelics. Several biopharmaceutical companies are developing psychedelic-based treatments for various mental health conditions, and in 2017 the FDA approved MDMA (Ecstasy) and psychedelic adjuvant for the treatment of post-traumatic stress disorder. It has given groundbreaking status to psychedelic supportive therapy that uses both therapies (active ingredients for mental health conditions). “magic” mushrooms) for depression. If a government agency gives these products the go-ahead, they could become much easier to access for researchers and possibly patients.

MDMA and psilocybin have long been listed as Schedule I drugs, along with other psychedelics. The US Drug Enforcement Administration (DEA) defines it as “a drug, substance, or chemical that does not currently have medical uses and that has a high potential for abuse.” ”

However, “once a Schedule I drug is approved for treatment by the FDA, the DEA must reschedule that particular formulation within 90 days,” said the nonprofit Multidisciplinary Association for Psychedelic Research (MAPS). said Betty Aldworth, director of communications and marketing at . bio space.

Betty Aldworth_MAPS [square]
Betty Aldworth

He added that that does not mean the US government will completely deregulate these drugs. It is also possible that the DEA will simply delist only those formulations that have been approved by regulators.

“For example, the FDA has approved cannabis-derived drugs for prescription use, but marijuana itself remains a Schedule I drug,” Aldworth said. Nevertheless, such approval could set a precedent for other companies working to bring psychedelic-based treatments to market.

The US government has said it is willing to study these drugs as medicines. In 2022, intercept Released a letter from Miriam E. Delphine Littmon, administrator of the Substance Abuse and Mental Health Services Administration, which said, “Too many Americans struggle with mental health and substance use problems, and that It is exacerbated by the ongoing COVID-19 pandemic.” , and . . . We must explore the potential of psychedelic adjuvant therapy to address this crisis. ”

Meanwhile, changes to state laws regarding psychedelic drugs are being introduced one after another across the United States.

Despite all this momentum behind the therapeutic psychedelic drug movement, Aldworth said the current economic situation remains uncertain at best, and that the neuropsychedelics sector is no different than other biopharmaceuticals. Point out that you will face challenges. In fact, she said she’s already seen several psychedelic startups facing layoffs and treatment clinic closures as their cash reserves dwindle.

Nonetheless, Aldworth said recent clinical data show the science behind these psychedelic drugs is better than ever, and the industry is poised to explode. said to believe. Several psychedelic companies are reporting strong growth as companies await the regulatory fate of MDMA and psilocybin.

The psychedelic drug market is expected to reach an estimated $8.31 billion by 2028, according to a report from InsightAce Analytic, a market research and consulting firm.

A new but growing industry

MindMed is the first U.S. psychedelic-focused pharmaceutical company to go public in 2019. MindMed’s shares soared on April 14 after the company announced positive results from a Phase II trial testing LSD (popularly known as acid) as a treatment. Options for people living with Major Depressive Disorder (MDD). The NIH estimates that 21 million US adults live with her MDD. At least 10% of Americans will experience MDD at some point in their lives, and women are twice as likely as men to be affected, according to Stanford Medicine’s Brain Functional Genetics.

Robert Barrow_Mindmed
Robert Burrow

CEO Robert Barrow said: bio space MindMed manufactures a proprietary form of LSD that is being used in trials for MDD and generalized anxiety disorder (GAD) to show how low, repeated doses of LSD can treat symptomatic patients. He said he plans to publish a proof-of-concept study soon to show how this could help. ADHD.

“Almost everyone in our company . . . has been affected by a mental health epidemic that has gone wrong for years,” Barraud said. One of the company’s goals, he added, is to reposition the long-legalized drug as a potent drug for a range of mental illnesses.

Meanwhile, in January, Small Pharma announced positive topline results from a Phase IIa trial of DMT, the first placebo-controlled efficacy study exploring short-term psychedelic drugs for the treatment of MDD. The company is currently planning new research, including a Phase I trial comparing DMT with selective serotonin reuptake inhibitors (SSRIs), commonly prescribed antidepressants.

MindMed and Small Pharma are two of the more established players in the space, but there are also some start-ups. In November 2022, Sensorium Therapeutics raised $30 million in Series A funding to develop psychoactive molecules for neuropsychiatric disorders. The following month, COMPASS Pathways announced that COMP360, a synthetic form of psilocybin, showed an 86% remission rate in patients with type II bipolar disorder.

However, psilocybin treatment is at least several years away, Aldworth noted.

“Since the state-of-the-art psilocybin-assisted therapy is currently in early phase III studies, it is unlikely that the FDA will evaluate the therapy for approval before 2025,” she said.

In the shorter term, MDMA-based therapy may be possible. In 2021, MAPS completed a Phase III clinical trial, reporting positive results from combining MDMA and psychotherapy for patients with severe post-traumatic stress disorder (PTSD).

“This trial builds on the promising results of a Phase II clinical trial that MAPS has completed, and is subject to approval by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD. This is the final phase of a study requested by MAPS, which should be combined with outpatient treatment in residential accommodation,” MAPS said on its website.

MAPS Chief Communications Officer Blair Clark-Shove said MDMA-assisted therapy could receive FDA approval as early as 2024. bio spacesaid MAPS plans to submit an NDA in the second half of this year.

“Thirteen million Americans live with PTSD, and it’s just one of the symptoms that may be treatable with psychedelics,” Aldworth said.

Navigate IP

Patent law is a complex and costly process for biotech start-ups, especially for psychedelic companies. Because the drugs they manufacture are still federally illegal substances. But with all of this poised to change in the years to come, Paul J. Molino, managing partner of Chicago-based patent firm RMMS, said the April 2023 Association of American Pharmaceutical Scientists At the National Biotechnology Conference, he said he expected a flurry of psychedelic drugs. Companies must secure intellectual property for therapeutics.

“The research into psychedelics for therapeutic purposes is a huge field,” he said. “There are some companies that are keeping an eye on us.”

MindMed’s Barrow said clinically the window is wide open.

“Given the enormity of the need and the views this class of drugs may bring, there is a lot of room for many companies to succeed.”

Joanna Smiley is a freelance science writer based in Connecticut. Visit her web her site or her LinkedIn her profile to contact her or browse more of her work.

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