Key highlights:
• Breakthrough Therapy Designation ensures that FDA will work closely with MAPS to complete Phase 3 trials as efficiently as possible
• MAPS and FDA have also reached agreement on design, primary endpoint, and statistical approach for Phase 3 trials
• Posttraumatic stress disorder (PTSD) is a serious and life-threatening psychiatric condition with unmet medical need despite available treatments.
• MAPS is sponsoring two Phase 3 clinical trials of MDMA-assisted psychotherapy in patients with severe PTSD starting in 2018
• MAPS, a non-profit research organization, has raised or pledged half of the $25 million estimated cost of these trials, with $12.5 million still needed
Quoting: ~ [link to www.maps.org]
“In July, the Food and Drug Administration took the important step of approving two final-phase clinical trials to determine whether a party drug that has long been on the Drug Enforcement Administration’s Schedule I list of banned substances could be used to treat a psychiatric condition that afflicts millions. The drug is MDMA, a psychedelic commonly known as Ecstasy, previously deemed to have “no currently accepted medical use.” The trials aim to determine whether the drug is, as earlier trials have suggested, a safe and effective treatment for post-traumatic stress disorder, when combined with psychotherapy.
The F.D.A. approval is a beacon of hope for the roughly eight million Americans believed to suffer from PTSD, a group that includes victims of abuse, refugees and combat veterans. The shortcomings in the way we have typically treated PTSD mean that many are condemned to suffer from the condition for years, even decades, with little relief. Less than 20 percent of patients are estimated to get effective treatment through prescription psychiatric drugs like Prozac, Paxil and Zoloft, which, along with psychotherapy, have been the global standard of mental health care since the 1990s.
This could change with the F.D.A.’s decision, which has given MDMA-assisted psychotherapy for the treatment of PTSD the status of a potential “breakthrough therapy.” Based on promising early results, this designation permits the fast-tracking of trials in hopes of proving the drug, which has psychedelic and stimulant effects, to be safe and capable of doing what no other drug on the market can.
After years of struggling in silence, I began to hear stories about others who had suffered from crippling PTSD, then had their lives transformed by guided therapeutic sessions with MDMA. I knew those offering this underground treatment were breaking the law, but I had to try it. I wanted my mind back. It worked. MDMA-assisted therapy allowed me to overcome the trauma and return to the person I had been before I was attacked.
To be sure, there are risks to MDMA-assisted therapy. Like any drug, MDMA has side effects, which can include sweating, sleeplessness, memory problems, and rapid heartbeat. There’s also a moderate risk of addiction, although it’s much lower with MDMA than with opioids.
Also, finding treatment means resorting to practitioners who are generally well intentioned but not mental health professionals. MDMA itself is still illegal; possession is a felony in some states. Determining the origin of the drug can be a difficult, too, and as with other street drugs, this underground MDMA carries risk of contamination by other, potentially dangerous substances.
All of these considerations make it more urgent to complete the trials and clear the way to safe clinical uses of the drug therapy. With the F.D.A.’s decision, MDMA-assisted psychotherapy has cleared one great hurdle: the regulatory restrictions on conducting research with Schedule I drugs. But another obstacle still stands in the way: money.”
https://mobile.nytimes.com/2017/11/03/opinion/ecstasy-ptsd.html?referer=http://m.facebook.com/
