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Critics of Lykos’ MDMA trials come out in force at meeting as FDA committee denies approval request

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A panel of independent health advisers convened Tuesday to consider a landmark proposal to approve MDMA as a treatment for post-traumatic stress disorder. In the end, Lykos’ MDMA drug approval proposal to treat PTSD failed with a 1-10 vote, reducing the chance for federal approval later this summer.

The Psychopharmacologic Drugs Advisory Committee, which advises the Food and Drug Administration on such issues, reviewed the latest research on MDMA, from studies conducted by Lykos Therapeutics, a spinoff of the Multidisciplinary Association for Psychedelic Studies (MAPS). During the trials, patients who received MDMA as part of an intensive, four-month course of talk therapy reportedly experienced significantly lower PTSD scores versus those who did not receive the drug, according to data presented to the panel.

However, the agency expressed concerns about the reliability of the data and potential safety risks associated with the drug, including heart problems and the potential for abuse. In addition, critics of the trials themselves came out in force to participate in the public comment portion of the meeting.

“This application is both consequential and complex,” FDA reviewer Dr. Tiffany R. Farchione noted at the beginning of Tuesday’s meeting.

‘More research’ needed

Following the open public hearing, the committee discussed the available data on the effectiveness and safety of MDMA-assisted psychotherapy for PTSD. Several panel members expressed concerns about the potential impact of functional unblinding, expectation bias, and the limited diversity of study participants on the interpretation of efficacy results. They also noted the lack of long-term safety data, the potential for abuse and diversion, and the need for robust patient safeguards.

When asked whether the available data showed that MDMA is effective in patients with PTSD, the committee voted 9-2 that the evidence was not sufficient to demonstrate efficacy, citing the various confounding factors and limitations in the data.

The committee also voted 10-1 that the benefits of MDMA-assisted psychotherapy with the FDA’s proposed risk evaluation and mitigation strategy do not outweigh its risks for the treatment of PTSD at this time. While acknowledging the promising nature of the therapy and the urgent need for new treatments, most panel members felt that more research was needed to address the outstanding questions and concerns regarding safety, efficacy, and the therapeutic approach.

“I think the greatest strength of the treatment is also its greatest liability. And that’s therapist in the room, the psychotherapy. And unfortunately, that sounds like it’s out of the direct purview of the agency,” said Dr. Walter Dunn, a UCLA researcher, who voted yes on risk-benefit.

The FDA will consider the advisory committee’s recommendations as it decides whether to approve MDMA-assisted psychotherapy for the treatment of PTSD. Although the agency is not bound by the committee’s votes, the overwhelming lack of support for approval at this time suggests that more data may be required before MDMA can be made available as a legal treatment option for PTSD patients.

“I think that this treatment is incredibly promising and has a lot of potential to help a lot of patients,” said Dr. Melissa Barone of the VA Maryland Healthcare System, who voted no on risk-benefit. “I just think that there needs to be more research done to address some of the questions and concerns that have been brought up today.”

Red flags

While taking public statements, the panel heard from a diverse range of stakeholders, including veterans, mental health professionals, researchers, and individuals with personal experiences related to PTSD and MDMA therapy.

Supporters of the therapeutic use of MDMA included Brian Dempsey from the Wounded Warrior Project, who advocated for the potential of MDMA-assisted psychotherapy to help veterans with PTSD, citing the high prevalence of the condition and the need for innovative treatments.

Deran Young from Black Therapist Rock also advocated for the potential of MDMA-assisted therapy to address racial trauma.

“Compared to psychedelic assisted therapy, which is like riding a motorcycle in terms of racial trauma, MDMA assisted therapies offers a significant beacon of hope,” Young said.

Still, red flags regarding Lykos’ leadership and clinical model were laid out during the hearing.

Meghan Poisson, a phase 2 clinical trial participant recruited by Lykos, shared her traumatic experience during the trial. In a statement read by proxy Sarah Grosch, Poisson alleged that she was subjected to physical and sexual assaults during MDMA-assisted therapy sessions, despite not consenting to being “blindfolded, gagged, pinned, cuddled, and caressed.” Poisson also claimed that she became suicidal during the trial, but Lykos failed to document this adverse event.

“The clinical trial shattered me. Overwhelmingly vulnerable, I was trafficked by my therapist while still in the clinical trial,” Poisson said. She urged the FDA to seriously consider its responsibility for patient safety and to reconsider the veracity of Lykos’ claims.

Independent investigative journalist Sasha Sisko, a survivor of PTSD, raised several concerns about alleged misconduct by Lykos and its founder, Richard Doblin. Sisko highlighted incidents such as the assault of Poisson, proposals to enroll Ukrainian refugees in MDMA-assisted group therapy trials, and the promotion of off-label use of MDMA-assisted couples therapy.

Journalist Russell Hausfeld, who has followed Lykos Therapeutics for years, raised concerns about the company’s handling of clinical trial data and alleged mistreatment of participants. One veteran quoted by Hausfeld said, “I watched as Lykos and its researchers used veterans up and discarded them as soon as they no longer served a useful purpose, regardless of mental health consequences or social implications.”

Bo Wittka, who experienced severe symptoms following a guided MDMA therapy session, stressed the importance of proper therapist training and patient support.

“The frightening state I am in, and if I learned to cope with to the best of my ability, began immediately following a single guided MDMA assisted therapy session on Feb. 19, 2023,” Wittka stated, adding, “There is zero support for people like me and absolutely no safety net in place.”

Former members of the psychedelic research community, including the Rev. Joe Welker, who heads a Presbyterian congregation in Vermont, alleged that Lykos leadership used the MDMA trials to advance a religious and spiritual agenda, with instances of abuse and misconduct against trial participants.

“While Lykos leadership may envision a spiritualized humanity, in this very study, Lykos treated the people who were harmed under their care with a falsely spiritual inhumanity,” Welker said.

If ultimately approved, MDMA would become the first illegal psychedelic substance to gain mainstream medical acceptance.



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Nebraska medical cannabis regulations stall in legislative committee

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A Nebraska legislative committee voted 5-3 against advancing a bill designed to implement and regulate the state’s medical cannabis program, leaving legislators and advocates searching for alternative paths forward, according to the Nebraska Examiner.

The General Affairs Committee rejected Legislative Bill 677, sponsored by State Sen. Ben Hansen of Blair, during a Thursday vote where committee members declined to offer amendments to the legislation, the publication reported.

“I don’t want to shut all the doors right now, but some doors are closing, and they’re closing fast, and so we have to act,” Hansen told reporters after the vote, according to the Examiner.

Nebraska voters approved medical cannabis in November 2024, with residents legally permitted to possess up to 5 ounces with a healthcare practitioner’s recommendation since mid-December. However, the regulatory commission created by the ballot initiative lacks effective power and funding to regulate the industry.

Hansen described his legislation as “a must” for 2025 to prevent a “Wild West” scenario in the state’s cannabis market. The bill would have expanded regulatory structure through the Nebraska Medical Cannabis Commission and extended deadlines for regulations and licensing to allow more time for implementation, the Examiner noted.

Committee disagreements centered on proposed restrictions. A committee amendment would have prohibited smoking cannabis and the sale of flower or bud products while limiting qualified healthcare practitioners to physicians, osteopathic physicians, physician assistants or nurse practitioners who had treated patients for at least six months.

The amendment also would have limited qualifying conditions to 15 specific ailments including cancer, epilepsy, HIV/AIDS, and chronic pain lasting longer than six months.

State Sen. Bob Andersen of Sarpy County opposed allowing vaping due to concerns about youth drug use, while committee chair Rick Holdcroft suggested selling cannabis flower would be “a gateway toward recreational marijuana,” a claim Hansen “heavily disputed,” according to the Examiner.

Hansen now faces a difficult path forward, requiring at least 25 votes to pull the bill from committee and then needing 33 senators to advance it across three rounds of debate, regardless of filibuster attempts.

Crista Eggers, executive director of Nebraskans for Medical Marijuana, remained optimistic despite the setback.

“This will not be the end,” Eggers said, according to the outlet. “Giving up has never been an option. Being silenced has never been an option. It’s not over. It’s not done.”

The legislative impasse is further complicated by ongoing litigation. Former state senator John Kuehn has filed two lawsuits challenging the voter-approved provisions, with one appeal pending before the Nebraska Supreme Court. The state’s Attorney General is also trying to do something about the hemp question, akin to other states across the country.



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One of Las Vegas’ cannabis lounges closes its doors

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Nevada’s cannabis lounge experiment faces some expected growing pains, with one of just two state-licensed venues closing its doors after barely a year in business, according to the Las Vegas Weekly.

“The regulatory framework, compliance costs and product limitations just don’t support a sustainable business model,” said Thrive Cannabis managing partner Mitch Britten, who plans to convert the space into an event venue until regulations loosen up.

The closure leaves Planet 13’s Dazed Consumption Lounge as the only operational state-regulated cannabis lounge in Nevada. Dazed manager Blake Anderson estimates the venue attracts around 250 customers daily, primarily tourists. One other establishment, Sky High Lounge, has operated since 2019 on sovereign Las Vegas Paiute Tribe land exempt from state regulations.

Even with Nevada regulators conditionally approving 21 more lounge licenses, potential owners are struggling to meet the $200,000 liquid assets requirement – particularly social equity applicants from communities hit hardest by prohibition.

Recreational marijuana has been legal statewide since 2017, but public consumption remains prohibited. That’s created an obvious disconnect for the millions of tourists who visit Las Vegas annually but have nowhere legal to use the products they purchase. The state recorded roughly $829 million in taxable sales during the 2024 fiscal year.

“It always comes down to money, and it’s difficult to get a space if you can’t afford to buy a building. On top of that, getting insurance and finding a landowner who’s willing to lease to a cannabis business is a challenge in and of itself,” said Christopher LaPorte, whose consulting firm Reset Las Vegas helped launch Smoke and Mirrors, told Las Vegas Weekly.

Many think the key to future success lies in legislative changes that would allow lounges to integrate with food service and entertainment – playing to Las Vegas’s strengths as a hospitality innovator. In the meantime, the industry will continue to adapt and push forward.

“Things take time,” LaPorte said. “There’s a culture that we have to continue to embrace and a lot of education that we still have to do. But at the end of the day, tourists need a place to smoke, and that’s what these places are.”



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Psyence Group consolidates its shares

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Psyence Group Inc. (CSE: PSYG) told investors that it will be consolidating all of its issued and outstanding share capital on the basis of every 15 existing common shares into one new common share effective April 23, 2025 with a record date of April 23, 2025. As a result of the consolidation, the issued and outstanding shares will be reduced to approximately 9,387,695 on the effective date.

This is the second time a Psyence company has consolidated shares recently. In November, its Nasdaq-listed associate, Psyence Biomedical Ltd. (Nasdaq: PBM), implemented a 1-for-75 share consolidation as the psychedelics company worked to maintain its Nasdaq listing.

Psyence Group reported earnings in February when the company delivered a net loss of C$3 million and was reporting as a going concern. At the end of 2024, the company said it had not yet achieved profitable operations, has accumulated losses of C$48,982,320 since its inception.

Total assets at the end of 2024 were C$11,944,478 and comprised predominantly of: cash and cash equivalents of C$10,611,113, other receivables of C$159,808, investment in PsyLabs of C$1,071,981 and prepaids of C$68,243.

Still, the company is pushing ahead. Psyence told investors that it has historically secured financing through share issuances and convertible debentures, and it continues to explore funding opportunities to support its operations and strategic initiatives. “Based on these actions and
management’s expectations regarding future funding and operational developments, the company believes it will have sufficient resources to meet its obligations as they become due for at least the next twelve months,” it said in its last financial filing.

The company said it believes that the consolidation will position it with greater flexibility for the development of its business and the growth of the company.

 



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