FDA could approve MDMA and psilocybin in 2 years

To deal with a worsening mental health crisis in the U.S., the FDA is reportedly considering approving 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin within the next two years, according to a letter from a Substance Abuse and Mental Health Services Administration (SAMHSA) published by The Intercept. 

MDMA could be authorized as a treatment for post-traumatic stress disorder, while psilocybin could be authorized for treating depression. 

Both drugs have received Breakthrough Therapy Designation from the FDA. 

Clinical trial data suggest that MDMA and psilocybin, when paired with psychotherapy, can offer substantial therapeutic value to many patients. 

“SAMHSA agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis,” wrote Assistant Secretary for Menta…

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10 emerging antidepressants to keep an eye on

[Zuranolone image courtesy of Wikipedia]

Antidepressants remain some of the most widely prescribed drugs, but most popular antidepressants are now available as generics. While selective serotonin reuptake inhibitors (SSRIs) and SNRIs (serotonin and norepinephrine reuptake inhibitors) remain the most commonly prescribed antidepressants, various new types of drugs may be available in the future. For example, drug companies are working on getting everything from an opioid kappa receptor antagonist to an oral neuroactive steroid on the market for depressive disorders.  

Here, we survey 10 antidepressants that may change the mental health landscape in the coming years.  

1. Esmethadone

The (S)-enantiomer of methadone, esmethadone (dextromethadone; REL-1017) from Relmada Therapeutics (Nasdaq:RLMD) is headed to a Phase 3 study for major depressive disorder (MDD). The drug candidate was efficacious on days 4, 7 a…

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Compass Pathways names Big Pharma veteran as new CEO

Psilocybin-focused mental health company Compass Pathways (Nasdaq:CMPS) has seen its share price steadily decline since late last year. In early November, 2021, its share price flirted with reaching $50 per share. On July 18, CMPS shares closed at $13.02.

Today, however, the shares were up 6% in mid-day trading, hovering around $13.80, after the company announced it would install a new CEO on August 1.

Kabir Nath will replace the company’s current CEO and chairman, who will assume the role of executive chairman until the end of the year.

Kabir Nath

“I am grateful for this opportunity and excited to get to know all our teams here at Compass Pathways as well as the members of our community,” Nath wrote on LinkedIn, “This is an exciting time to be joining Compass and I can’t wait to see what we will accomplish together.”

Nath is a veteran of the life sciences industry, having held senior ro…

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Clairvoyant begins Phase 2 psilocybin study for alcohol use disorder

Clairvoyant Therapeutics, a Canadian drug developer, has initiated the first of 15 planned sites for the Phase 2 CLARITY clinical study investigating the use of magic mushroom molecule psilocybin to treat alcohol use disorder (AUD).

The randomized, placebo-controlled study will evaluate the safety and efficacy of 25 mg of synthetic psilocybin with Motivational Enhancement Therapy (MET), a counseling method designed to elicit an internally motivated behavior change regarding substance abuse.

The CLARITY trial has won regulatory approval. Clairvoyant is currently working on obtaining regulatory approval to expand the trial to a number of EU countries.

Edmonton, Alberta-based Clairvoyant Therapeutics aims to win regulatory approval for psilocybin therapy in the EU, UK and Canada by 2026.

The CLARITY trial provides “a great opportunity to advance the science on psilocybin than has historically been done,” said Greg Engel, Clairvoyant Thera…

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How Cybin aims to maximize the potential of two classical psychedelics 

Classical psychedelics can be agents of chaos. In sufficient doses, they can trigger experiences of ego death or dissolution, as researchers have noted since the 1960s. Psychedelics can also help promote neural plasticity and uproot negative patterns to treat challenging-to-treat mental health disorders. FDA has acknowledged the potential of psilocybin for mental health by twice granting Breakthrough Therapy Designation status to the compound as a potential therapy for serious depression. 

The startup Cybin (Toronto, Canada) aims to harness the therapeutic potential of psychedelics while minimizing possible adverse side effects. 

Cybin’s deuterated psilocybin analog CYB003 could treat major depressive disorder (MDD) and alcohol use disorder (AUD) while potentially being better tolerated than traditional psilocybin. 

CYB003 is the company’s first focus as psilocybin is the most studied psychedelic molecule in academic studies “with decad…

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How psychedelics could address unmet need in mental health

[Image courtesy of Pixabay]

Interest in the therapeutic potential of psychedelics is booming, given their therapeutic potential for treating depression and other conditions. It is telling that psychedelics were among the hottest topics at the World Economic Forum (WEF) meeting this year in Davos, Switzerland, prompting mockery from late-night comics. 

Although the field remains embryonic, part of the reason for the recent interest in psychedelics is their potential to address difficult-to-treat mental health conditions. For example, research such as the U.S. government-backed Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study “showed us that our available medications are not as effective as we’d hoped they would be,” said Dr. John Krystal, chair of the department of psychiatry at Yale University, in a recent webinar from Cybin (Toronto, Canada). For depressed who respond to s…

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Psilocybin holds therapeutic promise — but tapping its potential could be a challenge

Communication between brain networks in people given psilocybin (right) or a non-psychedelic compound (left). [Image courtesy of Wikimedia Commons]

A growing number of small studies indicate that psilocybin, a psychoactive compound in hallucinogenic mushrooms, holds promise for treating depression, addiction and anxiety.

But while traditional psychedelics like psilocybin may have broad potential, making effective therapeutic use of them at scale is likely to be challenging in the near term, said psilocybin advocate Derek Chase, who has experience working in the pharmaceutical, cosmetic and cannabis industries.

“The mental health segment needs to be readdressed from the ground up” to make the most of psychedelics, Chase said. With psychedelics, the mental health industry should strive to find a “true linking of medication with therapy.”

Psychedelics such as psilocybin should …

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Psilocybin lit up the brains of people with severe depression in small study

Psilocybin image courtesy of Wikimedia Commons

A British study enrolling 43 people with severe depression found that the magic mushroom compound psilocybin bested the antidepressant Lexapro (escitalopram).

The blinded study published in Nature tracked patients’ symptoms and used functional magnetic resonance imaging (fMRI) to measure the brain’s metabolic function.

Those who received psilocybin weeks showed significant and sustained reductions in depressive symptoms, while fMRI scans showed prominent neural activity throughout the brain that lasted three weeks. In addition, the brain activity of psilocybin recipients was similar to that of a healthy brain.

Conversely, those who received Lexapro had a slight improvement in symptoms and neural activity that continued to be limited to defined brain regions.

Last year, a small Phase 2 study published in NEJM found that psilocybin…

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Ninth Circuit tosses psilocybin case for lack of jurisdiction

Image courtesy of Wikipedia

A three-judge panel on the Ninth U.S. Circuit Court of Appeals refused to hear a lawsuit filed by Dr. Sunil Aggarwal, a hospice physician, and two cancer patients who sought psilocybin, a Schedule I drug, to treat anxiety and depression in terminally ill patients.

Aggarwal’s employer, the Advanced Integrative Medical Sciences (AIMS) Institute, had sought access to use a synthetic form of the psilocybin under the Right to Try Act and similar laws, which allows unapproved treatment options for those with life-threatening diseases or those unable to obtain novel treatments in clinical trials.

The Drug Enforcement Agency (DEA) argued in a letter to AIMS that right-to-try laws do not preempt the Controlled Substances Act (CSA).

A three-judge panel on the Ninth determined the letter from the DEA did not represent formal guidance and, therefore, the Court lacked jurisdictio…

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Why Tryp Therapeutics is exploring the use of psilocybin to treat chronic pain

Many researchers are exploring the potential of the psychedelic compound psilocybin to treat conditions such as depression and post-traumatic stress disorder.

But psilocybin offers broader therapeutic promise as it appears to spur neuroplasticity, according to Greg McKee, CEO of Tryp Therapeutics (San Diego).

The company is exploring the use of psilocybin-based drugs for treating eating disorders and chronic pain.

“There’s a lot of similarities mechanistically in terms of how psilocybin works to treat depression that we think could apply to treating pain,” McKee said.

Tryp is working with researchers who believe psilocybin can support neuroplasticity in a manner that reduces chronic pain. Tryp’s research partners believe psilocybin can help correct abnormal neural firing in patients with chronic pain and related conditions.

Greg McKee

If psilocybin promotes neuroplasticity in huma…

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Tryp Therapeutics announces research alliance with the University of Michigan 

La Jolla, Calif.–based Tryp (CSE: TRYP) is tapping the University of Michigan to test its TRP-8803 drug formulation against traditional oral formulations of synthetic psilocybin.

The psilocybin-based drug developer will also work with the university to compare TRP-8803 with conventional formulations of synthetic psilocybin. In particular, the university will perform pharmacokinetic analysis for blood samples from patients who received psilocybin via oral and novel delivery methods.

Additionally, Tryp expects the partnership with the University of Michigan to help advance TRP-8803 to Phase 2b clinical trials. The research alliance will explore the psilocybin-induced increase in neurophysiological complexity and psilocybin’s potential to reduce chronic central pain. The University of Michigan also will explore the impact of alternative delivery strategies of psilocybin on pain indices and insular glutamate and gamma-aminobutyric acid (GABA) levels.

Tryp ha…

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