After years of criminalization and marginalization, scientists have begun looking at LSD's medical benefits more closely, so much so that the Food and Drug Administration just issued a groundbreaking stamp of approval.
Biopharmaceutical company Mind Medicine announced March 7 that the FDA has awarded "breakthrough therapy" status to its trial of patients using MM120 (lysergide D-tartrate) to treat anxiety. MindMed chief medical officer Daniel Karlin explained what the trial approval means going forward. "A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it," he told CNN. The move allows the FDA to "engage more closely in drug development" and speeds up the road to final approval as the agency is involved throughout the process.
MM120 is the codename for MindMed's lysergide D-tartrate compound, which resembles and delivers similar effects to lysergic acid diethylamide, known more commonly as LSD. In its ongoing trial, which kicked off in 2022, MindMed has so far found that a single dose of MM120 led to a 48-percent rate of remission from generalized anxiety disorder after 12 weeks following the drug’s administration. Scientists also noted significantly improved clinical signs of generalized anxiety disorder among 65 percent of patients within three months.
"The clinical improvement for many patients was more than double what we see with today’s standard of care," Karlin said. "This occurred at all levels of anxiety, from moderate all the way up to severe."
Related: LSD Could Help Alcoholics Stay Sober
Most recently, the researchers have been trying to determine the ideal dosage in its phase 2b trial. They tested people with anxiety's reaction to various doses of LSD, from 25 and 50 micrograms to 100 and 200.
"We’re very confident based on the results that 100 micrograms is the right dose to bring into our phase three studies, as we didn’t see any more improvement with 200 micrograms," Karlin said. He pointed out that at 200 micrograms, they observed "additional adverse effects."
They also found that MM120, unlike many forms of street LSD, did not give users a bad trip. It largely has to do with the grade of the drug and the way the company is making it. "LSD is difficult to manufacture with high purity and tends to degrade quickly in the presence of light and water," Karlin explained. "We’re manufacturing it to pharmaceutical industry standards, a highly pure version that is also shelf stable. So that’s a critical difference."
MM120 still has to go through the standard FDA approval process, including phase III trials, before it can become publicly available. But needless to say, the first medical study of LSD in over 40 years is already yielding some promising results.
from Men's Journal https://ift.tt/UtW3EHk
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