Lykos says report is flawed because it relies on limited sources and incomplete data.
The promising clinical trials investigating MDMA-assisted psychotherapy as a treatment for post-traumatic stress disorder (PTSD) have hit a potential roadblock. A week after the U.S. Food and Drug Administration announced a committee meeting June 4 to discuss Lykos Therapeutics’ new drug application for MDMA, a nonprofit called the Institute for Clinical and Economic Review, or ICER, issued a report raising several credibility issues.
ICER is an independent non-profit research institute that analyzes reports on drug efficacy claims.
ICER has raised concerns about the trial design and implementation. A key issue is the lack of true blinding, as participants could likely determine whether they received MDMA or a placebo due to the drug’s psychoactive effects. This casts doubt on the validity of the control group comparisons, according to ICER.
The report, published on May 14, also raised several ethical questions, including an allegation of sexual misconduct on the part of one trial therapist.
The concerns related to finding an adequate placebo are nothing new in psychedelic trials. It’s a challenge that many people have raised over the years, but one that’s difficult to avoid given the intense effects that psychedelics can produce over other drugs – like traditional antidepressants.
Psychedelic Medical News explored this issue in a Feb. 21 article about a researcher from Germany who suggests cannabis may be a more suitable placebo than other active substances used during trials.
Nearly all patients who received MDMA in two Phase III trials were able to correctly identify that they had been given the active drug due to its psychoactive effects, according to ICER. In addition, the report states that while unblinding always introduces potential for bias, this concern was amplified in these trials according to multiple experts.
“Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients, including discouraging reports of potential harms, potentially biasing the recording of benefits and harms,” the report stated.
ICER specifically called out Lykos Therapeutics, formerly MAPS Public Benefit Corp., for “design choices” that affected the trial outcomes and raised questions about potential misconduct that could have also impacted the results.
ICER began interviewing people involved in the trials after hearing about a podcast that discussed some of these concerns and then filed formal complaints with various agencies, including the FDA and Health Canada.
In response to the ICER report, Lykos Therapeutics issued a statement, saying ICER relied on limited sources and incomplete data.
“We stand behind the design and results of our clinical trials and are grateful to the patients and investigators who participated in them,” Lykos stated. “We are looking forward to discussing the benefit-risk profile of MDMA-assisted therapy for adults with post-traumatic stress disorder (“PTSD”) with the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) on June 4, 2024.”