(CNN) — Encouraging results from clinical trials have allowed the US Food and Drug Administration (FDA) to grant breakthrough therapy status to a formulation of LSD for the treatment of generalized anxiety disorder, it was announced this week. Thursday Mind Medicine Inc., a biopharmaceutical company that is developing Medicine
Dr. Daniel Carlin, associate professor of psychiatry at Tufts University School of Medicine in Boston and medical director of MindMed, said: “Breakthrough drug designation is recognition that a drug has demonstrated evidence of clinical effectiveness in addressing an unmet medical need associated with morbidity and mortality.
MindMed’s MM120 drug will follow the standard FDA approval process, including a Phase III trial.
The designation, however, is “an offer by the agency to be more closely involved in drug development,” Carlin said. “It affects response times and our ability to engage more with the agency to make sure we’re on board as we move forward.”
Two other companies also received breakthrough therapy status from the FDA: psilocybin for treatment-resistant depression and MDMA, (3,4-methylenedioxymethamphetamine), commonly known as ecstasy or molly, for post-traumatic stress disorder, or PTSD.
New results on effectiveness at 12 weeks
According to MindMed, a single dose of MM120 produced a 48% remission rate of generalized anxiety disorder within 12 weeks of taking the drug.
The drug MM120 also significantly improved clinical signs of generalized anxiety disorder in 65% of patients within three months, according to results from a phase 2b trial designed to test dosing levels, according to the company.
Anxiety is the most common mental disorder in the United States, affecting more than 40 million people over the age of 18 each year, according to the Anxiety and Depression Association of America. Generalized anxiety disorder is characterized by excessive and persistent thoughts that are difficult to control and interfere with daily activities.
“Clinical improvement in many patients was more than double what we saw with the current standard treatment,” says Carlin. “This has occurred at all levels of concern, from moderate to severe.”
Standard treatments for generalized anxiety disorder include cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors (SSRIs) and buspirone, which act on serotonin levels in the brain, as well as sedatives. called benzodiazepines.
Carlin explains that all of these drugs take time to work and may require experimenting with different doses, which adds time and cost to a patient’s treatment.
According to the Anxiety and Depression Association of America, anxiety is one of the most common mental disorders in the US. (PeopleImages/iStockphoto/Getty Images).
Determining the right dose
A multicenter, randomized, double-blind trial compared doses of 25, 50, 100, and 200 micrograms with placebo.
“Based on the results, we’re very confident that 100 micrograms is the right dose for our phase III study, because we didn’t see much improvement with 200 micrograms, but we did see additional adverse effects,” Carlin said.
Professor David Nutt, director of the Neuropsychopharmacology Unit in the Department of Brain Sciences at Imperial College London, which researches psychedelics, said in an email that the study results were “very exciting data for what can be a difficult to treat (anxious) population”.
“They expand the potential utility of psychedelic treatments beyond depression,” said Nutt, who was not involved in the research. “And again, as in the depression trials, a single dose produces long-lasting effects, perhaps because it breaks persistent negative thought processes.”
Although that was not the primary goal of the study, the results showed that MM120 also improved symptoms of depression, according to Carlin. “We saw a rapid and robust improvement in people’s depressive symptoms—the disease definitions in depression and anxiety overlapped.”
Without using psychotherapy
Most research with MDMA and psilocybin relies on the use of experienced clinicians who meet and establish rapport with participants before administering the drug. These therapists are available during the “journey” to help each person assimilate the experience, helping to ensure the lasting impact of any psychological insights.
However, in the MM120 study, psychotherapy was not used during the session. Instead, the monitors sat in the room to ensure safety, but spent time “mostly reading books,” Carlin said.
Psilocybin, how mushrooms can rewire the brain to overcome psychedelic, depression, anxiety and more.
“While previous research has documented the benefits of combining LSD with psychotherapy to alleviate anxiety associated with life-threatening situations, this groundbreaking study is the first to demonstrate that a single dose of LSD… effectively treats generalized anxiety without adjuncts to psychotherapy. Could, said Dr. Gabriela Gobi, a psychiatrist, professor and scientist at McGill University Health Center in Montreal and the Canada Research Chair in Mental Health Therapeutics, who did not participate in the clinical trial.
Carlin elaborates that compared to experiences with forms of LSD purchased illegally on the street, the MM120 level of study does not induce “bad trips.”
“LSD is difficult to make with high purity, and it degrades rapidly in the presence of light and water,” Carlin said. “We’re manufacturing it to pharmaceutical industry standards, a high-purity version that’s also shelf stable. That’s the fundamental difference.”
Most of the study’s adverse effects were rated as mild to moderate by participants, and occurred primarily on the day of the study, according to Carlin. These include feelings of euphoria, delusions and hallucinations, anxiety, unusual thoughts, headache, dizziness, nausea, excessive sweating, vomiting, numbness or tingling in the skin, and dilated pupils.
A long history of LSD research
According to Carlin, when the MM120 clinical trial began in August 2022, it was the first time LSD had been studied in a medical setting in more than 40 years.
In the 1940s and early 1950s, thousands of patients took LSD and other psychotropics to study their effects on cancer anxiety, alcoholism, opioid use disorder, depression, and post-traumatic stress disorder. PTSD. Researchers began to look at psychedelics as possible “new tools to shorten psychotherapy”.
But when Harvard University psychologists Timothy Leary and Richard Alpert were fired from the Harvard Psilocybin Project in 1963, after the university discovered they had been giving LSD to their students, the use of psychedelics for research began to lose its appeal.
Dr. Timothy Leary speaks about LSD at the League for Spiritual Discovery, April 7, 1967, in New York. (Photo: Eddie Adams/AP).
Leary began speaking publicly, encouraging young people to take LSD recreationally. He quickly became the face of the drug counterculture movement with his signature message: “Turn on, tune in, quit.”
LSD was no longer administered only to the relative safety of the laboratory or psychiatrist’s office, but horror stories about bad “acid” trips at universities and concerts began to appear, headlines appearing with images of protests. Against Vietnam and Woodstock participants.
In 1968, the United States banned LSD and research projects were shut down or forced underground. Then came the Controlled Substances Act of 1970, signed by President Richard Nixon. It classified all hallucinogens, including psilocybin, as Schedule I drugs: “substances with no currently accepted medical use and with a high potential for abuse.”
This story has been updated to more accurately reflect the FDA approval process.
