United States Drug Regulators Reject Ecstasy for Mental Health Treatment

istockphoto-1213293784-612x612 — Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

(TheConservativeTimes.org) – The United States had denied a motion to allow MDMA, commonly known as Ecstasy, as a possible therapeutic drug treatment for post-traumatic stress disorder, or PTSD.

The U.S. Food and Drug Administration was looking at the psychedelic drug to treat the mental health disorder in combination with talk therapy. Lykos Therapeutics, the drug maker, has said the agency denied the motion over concerns regarding limited data on whether “psychotherapy contributes to treatment benefit and if it is even necessary.”

The FDA stated that the lack of data prevented it from “concluding that this drug is safe and effective for the proposed indication.” The agency continued, “The FDA is responsible for ensuring drugs are both safe and effective.”

“In order to approve a drug, we must determine that the research and data submitted by the sponsor show that the drug is safe and effective for the intended use,” they said.

Lykos said they would continue working with the FDA but that additional research to prove their techniques could take years. They continued to say that using hallucinogens to treat PTSD is a great idea, but there is this setback.

This is the first time that the FDA has even looked at a psychedelic as something for medical use. MDMA is classified as a Schedule I under the Controlled Substance Act with cannabis and heroin.

Schedule I drugs are a category of drugs that aren’t accepted for medical use and “have a high potential of abuse.” MDMA has specifically been known to have therapeutic benefits for people who are suffering from some mental health disorders.

Advisors for the FDA were on the fence about the potential benefits of the drug. The vote was ten to one against the overall benefits of the drug when looking at it treating PTSD.

Nine out of the eleven advisors said that the available data didn’t show the effectiveness of the drug on patients who received it. However, Lykos studies showed that over seventy percent of patients no longer met PTSD criteria following the use of MDMA drugs.