Promising results from a clinical trial have earned an LSD formulation for treating generalized anxiety disorder breakthrough therapy status from the U.S. Food and Drug Administration, Mind Medicine, Inc. announced Thursday. The biopharmaceutical company is developing the drug.
“Breakthrough designation is recognition that a drug has demonstrated evidence of clinical effectiveness to meet an unmet medical need associated with morbidity and mortality,” said Dr. Daniel Carlin, assistant professor of psychiatry at Tufts University School of Medicine in Boston. ”. Chief Medical Officer of MindMed.
MindMed’s MM120 will continue to go through the standard FDA approval process, including a Phase III trial.
But the designation “is an offer from a government agency to be more closely involved in drug development,” Carlin said. “This will impact the timeline of our response and our ability to have more interaction with the agency to ensure we are reaching an agreement in stages as we move forward.”
Two other companies have 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 efficacy after 12 weeks
According to MindMed, a single dose of MM120 (lysergide tartrate) resulted in a 48% remission rate for generalized anxiety disorder within 12 weeks of administration.
The company said the MM120 drug also significantly improved clinical symptoms of generalized anxiety disorder within three months in 65% of patients, according to results from a Phase 2B trial designed to test dose levels. .
Anxiety disorders are the most common mental disorders in the United States, affecting more than 40 million people over the age of 18 each year. 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 life.
“The clinical improvement for many patients was more than double that seen with today’s standard of care,” Carlin said. “This happened with all levels of anxiety, from moderate to severe.”
The standard treatment for generalized anxiety disorder is a combination of cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors (SSRIs) or buspirone, which affect serotonin levels in the brain, and sedatives called benzodiazepines.
All of these drugs take time to become effective and may require experimentation with different doses, adding time and money to treating patients, Carlin said.
Determining the appropriate dosage
A multicenter, randomized, double-blind study tested doses of 25, 50, 100, and 200 micrograms compared to placebo.
“Based on these results, we are very confident that 100 micrograms is the appropriate dose to introduce into a Phase 3 trial. 200 micrograms does not show any further improvement. However, additional side effects were identified,” Carlin said.
Professor David Nutt, director of the neuropsychopharmacology unit at Imperial College London’s Department of Brain Sciences and who studies psychedelics, said in an email that the study’s findings “raise the possibility of treating difficult-to-treat people with anxiety disorders. “This is very exciting data about sexuality.”
“These studies have the potential to expand the usefulness of psychedelic treatments beyond depression,” said Nutt, who was not involved in the study. “And again, similar to the depression trials, a single dose would have a lasting effect, presumably because it disrupts persistent negative thought processes.”
Although that was not the study’s primary objective, the results showed that MM120 also improved signs of depression, Carlin said. “We saw rapid and steady improvement in people’s depression symptoms. Depression and anxiety have overlapping disease definitions.”
no psychotherapy used
Most studies on MDMA and psilocybin have relied on the use of trained therapists who meet with participants and establish a rapport before administering the drugs. These therapists are on hand throughout the “journey” to help each person absorb the experience and help ensure the lasting impact of their psychological insights.
However, the MM120 study was completed without the use of psychotherapy during sessions. Instead, the monitors sat in a room to ensure their safety, but spent their time “mostly reading books,” Carlin said.
“Previous studies have demonstrated the benefits of combining LSD and psychotherapy to reduce anxiety associated with life-threatening conditions, but this groundbreaking study shows that a single dose of LSD… This is the first to show that generalized anxiety can be effectively treated without the use of concomitant therapy.” Professor and Scientist, Department of Psychiatry, Canada Research Chair in Mental Health Therapeutics, McGill University Health Center, Montreal Physician Dr. Gabriela Gobbi says: She was not involved in the clinical trial.
Carlin said that compared to his experience using types of LSD purchased illegally on the street, the study grade MM120 did not appear to induce “bad trips.”
“LSD is difficult to produce in high purity and tends to degrade rapidly in the presence of light and water,” Karlin says. “We manufacture it according to pharmaceutical industry standards and it is a highly purified version that is also shelf-stable. So that is a crucial difference.”
Most side effects in the study were rated by participants as mild to moderate and primarily occurred on the day of the study, Carlin said. These include euphoria, illusions and hallucinations, anxiety, unusual thoughts, headaches, dizziness, nausea, excessive sweating, vomiting, numbness or tingling of the skin, and dilated pupils.
A long history of LSD research
When clinical trials for MM120 began in August 2022, it was the first time in more than 40 years that LSD had been studied in a medical setting, Carlin said.
From the 1940s to the early 1950s, tens of thousands of patients took LSD or other psychotropic drugs study their effects Cancer anxiety, alcoholism, opioid use disorder, depression, and post-traumatic symptoms stress disorder or PTSD. Researchers began to think that psychedelics were possible. ”New tools to shorten psychotherapy”
But when Harvard psychologists Timothy Leary and Richard Alpert were fired from the university, Harvard University Psilocybin Project In 1963, the use of psychedelics in research began to lose its luster when it was discovered that universities were giving LSD to students.
Leary began speaking out publicly, encouraging young people to take LSD recreationally. He quickly became the face of the drug counterculture movement. signature message“Turn on, tune in, drop out.”
No longer administered only in the relative safety of laboratories and psychiatrists’ offices, LSD became the subject of horror stories of terrible “acid” trips at universities and concerts. That headline appeared alongside images of anti-Vietnam protests and Woodstock participants.
In 1968, the United States outlawed LSD, and research projects were forced to shut down or go underground. Then came the Controlled Substances Act of 1970, signed into law by President Richard Nixon. It classified all hallucinogens, including psilocybin, as: schedule I drugs — Substances that have “no currently accepted medical use” and have a high potential for abuse.
Clarification: This story has been updated to more accurately reflect the FDA approval process.
