Single LSD dose provides lasting relief from anxiety, researchers find

A single dose of an LSD formulation designed to treat generalized anxiety disorder (GAD) can provide lasting relief within weeks, according to the biopharmaceutical company’s findings. 

MindMed, a psychedelic medicine biotech company, has been testing its MM120 (lysergide D-tartrate) – the salt form of lysergide, a hallucinogen commonly known as LSD.

On Thursday, the company said the U.S. Food and Drug Administration had granted breakthrough therapy designation to its LSD formula for generalized anxiety disorder. Such a designation by the FDA expedites the development and review of the drug, which "may demonstrate substantial improvement" over currently available therapies.

MindMed’s MM120 must still go through the FDA approval process, including a Phase 3 clinical program "in the second half of 2024."

Those who suffer from generalized anxiety disorder often have excessive worrying or anxiety about everyday issues and situations, according to the MayoClinic. They often overthink plans, can’t relax, and have difficulty concentrating. 

Physical symptoms can include fatigue, trouble sleeping, muscle aches, sweating, nausea, diarrhea, and irritability. 

An estimated 10% of U.S. adults, representing around 20 million people, suffer from the anxiety disorder, according to the researchers – although it’s likely underdiagnosed. 

FILE - In this photo illustration a man sits alone at a kitchen table on Jan. 17, 2021, in Bonn, Germany. (Photo by Ute Grabowsky/Photothek via Getty Images)

"I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety," Dr. David Feifel, an investigator in the study, said in a statement. "That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable."

"These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials," Feifel added.

LSD could be effective in treating anxiety, trial results show

MindMed said its Phase 2b trial found that 100 micrograms of MM120, a single dose of the LSD formula, led to a 48% rate of remission from generalized anxiety disorder after 12 weeks.

The drug also improved signs of generalized anxiety disorder for 65% of trial participants within 12 weeks, the company reported. 

MM120 was "generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug," MindMed said in a release on the findings.

The most common side  effects reported by patients on dosing day were hallucinations, illusions, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, dilated pupils and excessive sweating, MindMed said.

The trial tested doses of 25, 50, 100 and 200 micrograms of MM120 compared with a placebo, and without the use of other therapeutic interventions. 

Psychedelic medicine industry is growing

Money has been pouring into the psychedelic medicine industry, with dozens of startup companies vying to be among the first to sell mind-expanding drugs for depression, addiction, anxiety and other mental health conditions.

Psychedelics are still illegal under federal law, but companies are jostling to try and patent key ingredients found in magic mushrooms, ayahuasca and other substances that have been used underground for decades or — in some cases — for millennia by indigenous cultures.

About 50 such companies now trade on public stock exchanges, including developers of psychedelic drugs, retreats and training programs, according to the Associated Press. 

Some analysts project the industry could grow to over $10 billion within the decade.

A leading nonprofit in the field, the Multidisciplinary Association for Psychedelic Studies (MAPS), has been developing the first psychedelic medicine accepted for review by the FDA: MDMA, or ecstasy, to help treat post-traumatic stress disorder. The group’s pharmaceutical arm, the MAPS Public Benefit Corp., could win U.S. approval this year.

But as companies develop more psychedelic derivatives and combinations, deciphering their strengths and weaknesses will become more challenging, Dr. Jeffrey Lieberman of Columbia University told the Associated Press last month. 

Unless researchers can clearly demonstrate their benefits, they risk another backlash like the 1970 federal ban that wiped out psychedelic research for decades.

"Psychedelics could have tremendous benefit for treating a number of illnesses," Lieberman said. "But if we mess it up and rush the process, these drugs are going to get banned again, and you lose that opportunity."

This story was reported from Cincinnati. The Associated Press contributed.