[Adobe Stock] In August 2024, MDMA, which is better known as ecstasy, faced a setback as a potential therapy for PTSD —a complete response letter from the FDA. While its developer, Lykos Therapeutics, plans on launching a new Phase 3 trial with tighter scrutiny, another psychedelic company, MindMed, is readying a pivotal study of LSD for generalized anxiety disorder, another condition with scant and often negligibly effective treatment options. Giving a stagnant anxiety treatment landscape a push
“There has been little pharmaceutical innovation in anxiety treatment for decades,” says MindMed CEO Robert Barrow. SSRIs and SNRIs remain the first-line pharmacological treatments while benzodiazepines have faded somewhat owing to addiction worries. “The last FDA approval for anxiety was Cymbalta,” he said. While its original approval was for depression in 2004, the drug won an indication for Generalized Anxiety Disorder (GAD) in 2007. “That’s 20 years without a meaningful new drug in anxiety.” Robert Barrow The need for innovation is stark. Anxiety and depression disorders have “some of the highest impact on morbidity and general well-being,” Barrow said. A 2023 JAMA investigation found that patients with depression or anxiety had a roughly 40% higher long-term mortality rate than those without similar conditions. While new SSRIs have been developed, many patients remain untreated or undertreated. “We’ve seen virtually no innovation in either field, especially in anxiety,” Barrow noted. “The trajectory for these disorders has continued and even accelerated.”
Enter MM-120, MindMed’s lysergide d-tartrate—a pharmacologically optimized form of LSD that received FDA Breakthrough Therapy Designation in March 2024 . The company’s Phase 2b results showed promising outcomes: a 65% clinical response rate and a 48% remission rate in GAD patients, sustained over 12 weeks.
MM-120 Phase 2b Trial Results
Primary Endpoint (4 Weeks) 21.3 point HAM-A reduction
7.6-point vs placebo (p=0.0004)
78% clinical response rate
50% clinical remission rate
Extended Results (12 Weeks) 7.7-point vs placebo (p<0.003) 65% response rate 48% remission rate maintained Safety Profile 97.5% completion rate Mild-to-moderate side effects Common: illusions, euphoria, anxiety Dosing Doses tested: 25-200 µg Optimal dose: 100 µg Single administration Reimagining the patient experience After Albert Hofmann discovered LSD’s […]
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