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Could LSD change the game in anxiety treatment?

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A once-controversial psychedelic substance could potentially be a promising treatment for generalized anxiety disorder (GAD). That’s the view of Dr. Rakesh Jain, a psychiatrist with extensive experience in clinical practice, research, and education, affiliated with Texas Tech University School of Medicine. Jain expressed optimism in LSD-based therapy while acknowledging the challenges inherent in such a radical shift, in a recent MindMed analyst briefing on the heels of its MM-120 winning a breakthrough designation for an LSD-based treatment for GAD, based on promising topline data from a phase 2b study.

A once-controversial psychedelic substance could hold the key to treating Generalized Anxiety Disorder (GAD). This is the view of Dr. Rakesh Jain, a prominent psychiatrist who serves as a clinical professor at the Department of Psychiatry at Texas Tech University School of Medicine. While ack…

FDA grants breakthrough status to LSD-based anxiety treatment

In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector and specifically bolsters the future of MindMed.

[Related: Could LSD change the game in anxiety treatment?]

Psychedelic stocks: A long, strange trip continues

As with many psychedelic companies, MindMed’s stock (NASDAQ: MNMD) has been on a rollercoaster ride in recent years, briefly reaching close to $60 per share in early and mid-2021 amid peaking investor enthusiasm for the potential of psychedelic-based treatments. But the stock, like many others in the sector, has faced significant declines as investor enthusiasm waned later in 2021 and 2022.

The breakthrough therapy des…

LSD shows promise as standalone anxiety treatment in trial

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Phase 2b data from MindMed’s LSD-based therapy adds to the mounting evidence that psychedelic-assisted therapies could treat mental health conditions like anxiety, depression and PTSD.

In particular, the study found statistically significant dose-dependent improvements in the Hamilton Anxiety rating scale (HAM-A) at the 100 and 200 μg dose levels in the four-week study. Similarly, recent phase 2 Cybin data found 79% remission for depression after two doses of its psilocybin-based therapy. And MAPS filed for MDMA approval in PTSD based on phase 3 results.

But MindMed’s study was unique in its evaluation of MM-120 as a standalone single-dose oral medication without psychotherapy. The compound, an LSD tartrate formulation, showed clinically and statistically significant reductions in anxiety symptoms over four weeks when given as a single monotherapy dose in patients with generalized an…

Atai Life Sciences launches Phase 1 clinical trial of MDMA derivative

A growing number of companies have launched clinical trials for methylenedioxymethamphetamine (MDMA) and its derivatives.

The most recent is Atai Life Sciences, which saw its share price surge 7.71% in mid-day trading to $3.38 after announcing it had launched a Phase 1 study of an MDMA derivative, EMP-01. The study will focus on post-traumatic stress disorder (PTSD).

Last week, MindMed (Nasdaq: MNMD) announced that it had launched a Phase 1 study investigating MDMA-like substances in healthy volunteers.

Potential for PTSD and beyond

In 2020, Multidisciplinary Association for Psychedelic Studies (MAPS) completed a Phase 3 study of MDMA-assisted psychotherapy focused on PTSD. In addition, MAPS has Phase 2 studies underway for eating disorders, anxiety associated with a life-threatening illness and social anxiety in autism.

FDA has granted Breakthrough Therapy Designation to MAPS to test MDMA in PTSD.

Other companies investigating MDMA inclu…

MindMed announces Phase 1 study of MDMA-like substances

On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers.

MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early evidence suggests that its MM-402 MDMA-based drug candidate can reduce social impairment.

Like LSD, MDMA (methylenedioxy-methamphetamine) is a Schedule I drug. While the U.S. government outlawed LSD in 1968, MDMA was banned in 1985.

The FDA, however, is purportedly considering approving MDMA as a treatment for post-traumatic stress disorder in the coming years.

Matthias Liechti, principal investigator of the Phase 1 study on MDMA-like substances on behalf of MindMed, noted that the amphetamines MDMA and methylenedioxyamphetamine (MDA) can have mixed subjective effects — especially at the onset of response…

LSD-assisted therapy resulted in durable anxiety improvement in Phase 2 study

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A randomized placebo-controlled Phase 2 study found that lysergic acid diethylamide (LSD)–assisted therapy yielded significant reductions in anxiety and depression symptoms for up to 16 weeks.

The data from the study was recently published in the peer-reviewed Biological Psychiatry.

Researchers at the University Hospital Basel (UHB) conducted the investigator-initiated study, which involved 42 patients.

While there was a substantial amount of research on LSD-assisted therapy in the 1950s and 1960s, psilocybin has emerged as a more popular compound for psychedelic-based therapy in recent years.

In the data published in Biological Psychiatry, researchers used Spielberger’s State-Trait Anxiety Inventory–Global (STAI-G) score and the HAM-D-21 (Hamilton Depression Rating Scale) to quantify anxiety and depression, respectively. Investigators also used the Beck Depressio…

MindMed launches Phase 2b to study LSD in generalized anxiety disorder

Psychedelic medicine firm MindMed (OTCMKTS:MMDCF) has dosed the first patient in a Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD).

The study will test the potential of LSD to treat general anxiety disorder (GAD), which affects about 3% of the population.

While LSD emerged as the definitive psychedelic compound of the 1960s, psilocybin has more recently emerged as a more popular recent focus of clinical trials. LSD arguably has seen more cultural backlash than psilocybin.

Unravelling psychedelic mysteries

Evidence is mixed regarding LSD’s potential to treat mood disorders. Some LSD users report obtaining life-changing insights from their experiences. For instance, the actor Cary Grant reported experiencing an “immeasurably beneficial cleansing of so many needless fears and guilts” after ingesting LSD an estimated 100 times in a therapeutic setting from 1958 to 1961. Conve…

As interest in psychedelic medicine grows, Big Pharma sits on the sidelines

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While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building.

Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methylenedioxymethamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded that MDMA yielded a larger effect size than antidepressants Zoloft (sertraline) and Paxil (paroxetine).

The FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD in 2017. Approval could come in 2023, according to The New York Times.

[Related: Debate series considers the therapeutic promise and pitfalls of psychedelics]

Last month, NEJM summarized the results of a Phase 2 study that found that psil…