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The success of Psychedelic’s first Phase 3 will pave the way for the industry




Post-traumatic stress disorder is a psychiatric distress that is crippled and difficult to treat. The United States spends billions of dollars each year solely on veterans suffering from PTSD. So it’s encouraging to see the promising new treatment report released on Monday. Nature medicine..

As the first phase 3 trial of psychedelic drugs, the study is also at the forefront of a wave of excitement among therapists. And investors Potential healing of historically illegal substances such as cannabis, silo urinal mushrooms, ibogaine, and ayahuasca.

In the report on Monday, An international team of researchers describes a treatment test that combines psychotherapy with doses of MDMA (an illicit drug commonly known as ecstasy or molly). MDMA supportive care is dramatic in reducing PTSD symptoms and improving routine functioning in 42 treated participants compared to 37 participants who received psychotherapy and placebo. It was effective for.

Two months after the last drug support session, two-thirds of patients treated with MDMA became less fit for the diagnosis of PTSD than one-third of patients treated with placebo. While clearly significant in the patient’s life, the difference was also statistically very significant.

The news raised shares in most psychedelic drug developers, but they were not involved in MDMA research. Non-profit organization..Share

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(Ticker: CMPS) The Nasdaq Composite fell 2.6% on Monday, rising 5% to $ 35.77.

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(FTRPF) was up 13% to $ 5.18. Mind Medicine (MNMD) fell 6% to $ 3. Atai Life Sciences, awaiting the validity of the initial public offering prospectus, Berlin-based psychedelic company It aims to raise over $ 100 million in the Nasdaq IPO.

The MDMA study recruited 90 PTSD patients in the United States, Canada and Israel. Their average age was 41 years and they had been diagnosed with PTSD for an average of 15 years. Over 90% suffered from depression and struggled with suicidal ideation. Although PTSD is commonly associated with veterans, it is more common in women, with two-thirds of study participants being women.

Treatment included three preparatory psychotherapy sessions by a team of two therapists. The study participants then underwent three 8-hour treatment sessions after administration of either MDMA or placebo. Psychotherapy continued after the drug support session. The study was conducted in a double-blind manner, with external evaluators measuring participants’ PTSD symptoms and changes in daily function.

The US Food and Drug Administration has approved only a few antidepressants to treat PTSD, and about half of PTSD patients have not been released from these drugs. However, in the MDMA-assisted study, 67% of treated patients improved sufficiently and did not meet the diagnostic criteria for the condition, and one-third enjoyed complete remission after three drug-assisted sessions. In its prescribed use, MDMA did not cause major safety issues.

The· Nature The authors speculate that the MDMA-assisted session creates a “window of tolerance” that allows patients to reduce shame and anger and revisit traumatic memory without being overwhelmed by PTSD symptoms. Treatment worked equally well for patients with a history of substance and alcohol abuse.

Amy Emerson, CEO of MASP Public Benefit Corporation, who oversees MDMA research, said: Barron’s.. A rare company grows from 30 years of efforts by a non-profit group called the Interdisciplinary Association of Psychedelic Research (or MAPS) to overcome medical and legal obstacles to scientific research on banned psychotropic drugs. Did.

MAPS was founded by Rick Doblin in 1986, shortly after the federal government banned ecstasy. Over the next few years, he stubbornly raised millions of dollars, requiring dozens of researchers and lawyers to bring MDMA-assisted therapy to the Phase 3 finish line. “We are the oldest start-up in the world,” Doblin joked. Barron’s..

For-profit companies, on the other hand, seem to be sprouting everywhere to develop psychedelic drug treatments. Cannabis industry. Doblin cruelly points out that while MAPS still faces funding challenges, commercial ventures have raised hundreds of millions of dollars in the last two years.

Doblin, current executive director, said MAPS will require hundreds of millions more dollars. MAPS must complete a second Phase 3 trial before the US Food and Drug Administration considers treatment approval. Then it has to train therapists around the world to manage the treatment.

“For 32 years in our 35-year history, nonprofits like MAPS were the only way,” said Doblin. “There were no investors.” Doblin’s efforts have influenced other non-profit drug developers. American InstituteWe are conducting clinical trials of psilocybin for treatment-resistant depression.

Non-profit MAPS has great ambitions. It sponsors research on marijuana, LSD, ibogaine, and ayahuasca, and is working to legalize these substances as a tested and approved treatment. “No one for profit is talking about drug policy reform,” Doblin said. “The nonprofit model is innovative and you may need to touch something that a nonprofit organization doesn’t want to touch.”

To fund the testing and deployment of MDMA treatment, MAPS has established a public interest corporation. This is a legitimate business venture established in the last decade, where companies are society, workers and environment. In the United States, MAPS Public Interest Corporations enjoy a five-year exclusivity for MDMA-assisted treatment. The resulting income will fund therapist training. CEO Emerson said the company could also pursue revenue as a commissioned research organization conducting clinical trials for other psychedelic treatment developers.

According to Emerson, about 1,100 therapists have applied for training with MAPS, and more than 15,000 are seeking notification of training opportunities.

“Now it’s a hot new thing, but we’ve paved the way and in many ways made it easier for for-profit companies,” Emerson said.

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