FDA Grants Breakthrough Therapy Designation; For MDMA-Assisted Psychotherapy, Phase 3 Trials Approved; Promise Of Pure Ecstasy For PTSD Treatment

MAPS PRESS RELEASE: FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials

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



“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.”

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Psychedelic Therapy Gaining Traction: Ecstasy Step Closer To Phase 3 Clinical Trial, If Successful It Will Lead To MDMA’s Removal From Schedule 1

“The Food and Drug Administration is likely to approve a phase three clinical trial of MDMA-assisted psychotherapy, according to the

Multidisciplinary Association for Psychedelic Studies (MAPS), which met with the agency on May 11. A successful phase three trial–i.e., a randomly controlled, double-blinded study that demonstrates both efficacy and safety in a large patient population–would all but guarantee the drug’s eventual removal from schedule I of the Controlled Substances Act.

“At the meeting, all of the FDA’s concerns were addressed and no outstanding questions remain,” MAPS reported after its sit-down with the FDA earlier this month. There are no roadblocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and [MAPS Public Benefit Corporation’s] responses to FDA questions.”

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The Final Mental Health Revolution Is Underway:

“Psychedelics have a brand problem, but early studies suggest drugs like LSD and MDMA could treat disorders like post-traumatic stress disorder. Operative word being could. Bad branding means bad funding, so while those preliminary studies are promising, they’re also relatively rare.

Which is why today an organization called Fundamental is launching a crowdfunding campaign to finance an ambitious series of studies—designed under the watchful eye of the FDA, mind you—into how psychedelics might treat a range of psychological disorders. So should you be inclined, you can kick in cash to fund what is shaping up to be a bold and bizarre new frontier in medical research.

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Fundamental came from the brain of Rodrigo Niño, a real estate developer in New York who in 2011 was diagnosed with melanoma. Following two surgeries, Niño—understandably terrified of death—traveled to the Peruvian jungle to try ayahuasca, a powerful psychedelic famed both for its violent upheaval of the human digestive system and its tendency to take users on intense spiritual journeys. (Not exactly the most data-driven beginning to a psychedelic science campaign, but there it is.)

“Right after my first session—my ceremony, they call it—I was completely off my fear of dying,” Niño says. “Completely gone, you know. And then I had to know if what had happened to me was placebo effect caused by the hallucinations, or if in fact I had been physiologically cured.”

Problem is, you can’t just call up the federal government and ask for some money, pretty please, to test a schedule 1 drug on people. And good luck getting pharmaceutical companies interested in natural drugs they can’t slap a patent on. “The issue is that [psychedelics] don’t make money, and because they don’t make money traditional capital sources have no interest in them,” says Niño. And so Niño founded Fundamental to take psychedelics research to the people.

One of the first beneficiaries of the fund will be Amanda Feilding, a legendary figure in the psychedelics movement. The UN made a terrible mistake, she says, when in 1961 it passed the Single Convention on Narcotic Drugs, essentially Just Say No to Drugs in treaty form. “What we’ve been trying to do for the last 20 years,” Feilding says, “is provide governments and the UN with the scientific evidence so that they can amend or withdraw the conventions prohibiting these substances or lower them from schedule 1 to schedule 3 or 4 so that doctors can prescribe them and research can be done.” To do that, though, she’s relied on donations from individuals or grants from other institutions.

Another beneficiary of the crowdfunded cash will be Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies. With its cut of this new, larger round of crowdfunding, MAPS plans to bring sufferers into a clinic for three sessions of supervised dosing, after which the patient stays for the night. This is combined with 12 hour-and-a-half-long psychotherapy sessions.”

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Other Street Drugs With Most Medical Promise:

“The federal government’s five schedules under the Controlled Substances Act have a way to demonize those that they classify.

Meanwhile Scientists are hard at work to find the good in scheduled drugs. Not including marijuana since its medicinal effects are already highly marketed, here are three others whose potential benefits are lesser known, but are nevertheless inspiring new medical treatments for certain disorders, particularly those that affect mental health.

Ketamine For Depression:

Initially developed as a cleaner, or less psychosis-inducing, version of the anesthetic phencyclidine, ketamine has recently gained fame for its rapid antidepressant effects in both bipolar and, more notably, major depression. The known Schedule III anesthetic, which is also a horse tranquilizer and a chemical cousin to PCP (angel dust), was first clinically tested on depression when scientists used it as an NMDA receptor antagonist to test the role of NMDA receptors in depression. A 2000 double-blind study found that ketamine significantly improved depressive symptoms within seventy-two hours. But this study only included seven subjects.

When the pool size increased from seven to seventy-three, as in the well cited 2013 study, the conclusion fared even better for ketamine’s case against depression. In the study, chronically depressed individuals were randomly assigned to groups that either used ketamine or benzodiazepine midazolam, which is also an anesthetic but serves as the study’s placebo control since it doesn’t act as an NMDA antagonist. The researchers remarkably found that, just after twenty-four hours, 74 percent of the ketamine group reported an alleviation of depressive symptoms, while only 28 percent of the midazolam group did. The results seem to show that ketamine works as an antidepressant because of its NMDA receptor-blocking properties.

MDMA For Post-Traumatic Stress Disorder (PTSD)

The popular party drug MDMA (or ecstasy, though some claim that the two terms are somehow different) was created by a German chemist in 1912, fell off the map and later remerged in the 1970’s. Before the U.S. listed MDMA as a Schedule I drug in 1985, a study suggested that MDMA was particularly useful in helping patients open up during their psychotherapy sessions. In fact, some even called it the “penicillin for the soul.”

A couple of decades later, scientists caught wind of MDMA’s potential promise, and, in 2010, Mithoefer and colleagues performed the first randomized controlled pilot study of MDMA-assisted psychotherapy for PTSD. The 2010 study found that 83 percent of the MDMA group reported a marked decrease in PTSD symptoms, while only 25 percent of the placebo group did. After a few years, the same researchers followed up on their study, and found that 74 percent to 89 percent of those participants had long-term improvement

Magic Mushrooms For Depression And Anxiety:

The prehistoric magic mushrooms contain psilocybin, which is an agonist for a specific serotonin receptor that SSRIs, a commonly prescribed anti-depressant, don’t directly target. But psilocybin, though unique in attack, seems to have anti-depressant properties just the same. A 2016 studyfound that participants with treatment-resistant depression noticed a sharp decline in their symptoms after both one week and three months since ingesting a high dose of the psychedelic.

The results of psilocybin, which is a Schedule I drug, in fighting depression is profound enough that David Nutt, a director in the division of brain sciences at Imperial College London, said, “I’m absolutely sure that, within ten years, psilocybin will be an accepted treatment for depression.” If Nutt is right, then the legal versions of psilocybin and MDMA seem likely to end up on the public market at the same time.”

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h/t SN7


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