The FDA has given the “breakthrough therapy status” to MM120, a LSD-like substance that was tested in a clinical trial. It is being used as a treatment of generalized anxiety disorder.
Mind Medicine Inc. (or MindMed) the drugmaker behind MM120, said in a Thursday press release that it planned to hold a meeting with FDA at the end of Phase 2 in the first half 2024. It also stated in a second-half of the year a phase 3 clinical trial.
The results of the most recent round of studies showed that a single dose of MM120, (lysergide d tartrate), led to a “clinically significant and statistically significant reduction” in anxiety scores twelve weeks after administration. 65 percent of participants had a clinical response while 48 percent were in clinical remission.
The designation of a breakthrough drug is intended to acknowledge the therapeutic promise and speed up the development of new treatments. MDMA and Psilocybin were also awarded this designation in the past.
David Feifel is a professor emeritus of psychiatry from the University of California San Diego, and an investigator for the MindMed study. These results indicate the potential MM120 holds in treating anxiety. Those of us who work every day to relieve anxiety in our patients are looking forward to the results of future Phase 3 studies.
Unlike other psychedelic assisted therapies such as MDMA, which is used to treat PTSD in some cases, the trials on the efficacy MM120 didn’t include a psychotherapy or talk therapy component. MindMed stated that MM120 was given as a single dosage in a clinically monitored setting without any therapeutic intervention.
Robert Barrow said that the FDA’s designation of MM120 as a groundbreaking therapy for GAD, and the durability data obtained from our Phase 2b trial, “provide further validation” on the role that this treatment could play in addressing unmet needs among people with GAD. “We are committed in bringing MM120 and our pipeline of serious brain disorders to people with GAD.”
We announced today that the FDA granted breakthrough therapy designation to MM120 for GAD. We will be hosting a conference call to discuss the 12-week durability results from our Phase 2b GAD study. The call is scheduled for 8AM ET. Read more: https://t.co/1g7gYkE3by $MNMD pic.twitter.com/Y4w4gEG0NE
MindMed (@mindmedco 7 March 2024
According to a representative of MindMed in the media, MM120 “is a tartrate salt version of lysergide – a synthetic drug known as LSD.”
CNN’s Chief Medical Officer said that LSD is hard to produce with high purity, and it tends to degrade rapidly in the presence light and water. We manufacture it according to the pharmaceutical industry’s standards. It is a highly purified version, which is shelf stable. This is a crucial difference.
Participants in the study “clinically tapered” and then “washed out” of any antidepressant or anxiolytic treatments. They also did not receive any study-related psychotherapy during their participation.
Reid Robison is a psychiatrist, chief clinical officer of the Utah-based Numinus psychedelics firm, and an investigator in the study. He said, “The positive results give me hope this could translate into meaningful benefits to my patients.”
Robinson, a clinical researcher and clinician, said in a press release that he “applauded the way MindMed designed this study to isolate the effects of MM120 through the removal of confounding factors like additional medications and therapy.”
MindMed stated in its press release, that the most common adverse reactions for study participants were “illusions, hallucinations and euphoric feelings, anxiety, abnormal thoughts, headache, paresthesia dizziness, tremors, nausea, vomiting feeling abnormal, mydriasis, hyperhidrosis, and feeling abnormal.”
The American Psychiatric Association general meeting in New York, which is scheduled for May 4-8, will feature a presentation of the trial findings.
This is just the latest of a number of developments in the field of psychedelic therapies this year. FDA granted priority status last month to its evaluation of MDMA-assisted treatment as a possible treatment option for Post-Traumatic Stress Disorder (PTSD). According to Lykos Therapeutics, the agency is aiming to reach a decision by August 11.
The Drug Enforcement Administration (DEA), if the new drug application was approved, would have to reschedule MDMA. This would be the first time in history that a psychedelic was approved as a drug, administered with talk therapy or other supportive services.
The FDA published a draft guidance document on last year. It was the first of its kind. It outlined the “unique considerations” that researchers must take into account in studying psychedelics. According to the FDA, these drugs show “initial potential” as potential treatments.
Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that assign psychedelics-specific codes to collect data on the novel therapies.
Researchers at the Langone Center for Psychedelic Medicine at New York University and the Centre for Psychedelic Research of Imperial College London found in a recent study that pairing MDMA or psilocybin with LSD or psilocybin helped people overcome “challenging” experiences related to the use of psilocybin alone.
In 2022 the Biden administration stated that it was “actively examining” the possibility to create a federal taskforce to investigate the therapeutic potency of psilocybin and MDMA, among others, ahead of anticipated approval of these substances for prescription-use.
In California, Gov. Gavin Newsom, a Democrat from California, signed a law in October last year that allows doctors to prescribe certain drugs currently illegal like MDMA and psilocybin as soon as they are federally rescheduled.
In February of this year, Australia made MDMA and Psilocybin available by prescription.
LSD, and other similar substances, received less attention than MDMA and psilocybin in the past few years. In a study conducted last year, it was found that LSD and MDMA could be powerful pain-relieving substances, without the diminishing efficacy associated with opioids.
This article has been updated so that it reflects the fact that MM120, a tartrate-salt form of LSD, is now included.
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The post LSD like drug wins FDA breakthrough therapy status for treatment of generalized anxiety disorder first appeared on Marijuana Moment.
