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ICER report rebukes Lykos’ MDMA-AP study

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The Institute for Clinical and Economic Review (ICER) recently posted its revised evidence report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP, a psychotherapy protocol from Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).

ICER provides independent evaluations of medical tests, treatments, and systems.

The institute concluded that the current publicly available evidence is insufficient to assess the overall net benefit of MDMA-AP, which gave the company an “I” rating. ICER also stated that it would not provide Health Benefit Price Benchmarks for MDMA-AP based on that incomplete rating.

“PTSD can be a severe condition affecting nearly all aspects of an individual’s life,” said ICER’s Chief Medical Officer David Rind, M.D. “Current therapeutic options are insufficient for many people with PTSD. While MDMA-AP may be a promising therapy for PTSD, functional unblinding in the clinical trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms.

“It will be incumbent on regulators with complete access to primary data to carefully evaluate whether MDMA-AP has been proven safe and effective,” he added.

Concerns over study

Echoing many of the statements made to the FDA Advisory panel on Lykos and its MDMA study Tuesday, ICER said it had substantial concerns about the validity of the study.

Unblinding was one of the biggest issues, meaning study patients knew if they were taking MDMA and not a placebo. Plus, many of patients went into the study with a bias towards a positive outcome for the MDMA treatment.

The report stated, “Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients including discouraging reports of substantial harms, potentially biasing the recording of benefits and harms.”

ICER also said that it had received relatively little input from Lykos Therapeutics, the sponsor of the trials. After the publication of its draft report, Lykos submitted public comments but still has not engaged in dialogue with ICER about the issues.

The MDMA bubble

The report also found fault with the pool of therapists used in the study and that, in some cases, trial participants appeared to have pulled heavily from the existing community of those interested and involved in the use of psychedelics for possible psychological benefits. ICER also noted that some of the therapists had close relations with those running the clinical trials.

“This is unusual and heightens concerns about pressures to tailor reported results,” the report said.

Even darker comments entered the report when ICER wrote that, “Some participants felt they could be shunned if they reported bad outcomes or that it could lead to future patients being denied the benefits of MDMA-AP.”

It went on to say that some patients were told by their therapists that their negative outcomes were evidence that they were responding appropriately and would eventually improve. However, ICER found that some patients were prevented from entering the long-term follow-up study and felt this was done to keep these negative outcomes out of the data set.

Sexual boundaries

One issue that continues to haunt the Lykos study trial is a report of sexual misconduct. Despite the trial requiring dual treatment by one male and one female therapist, sexual boundaries apparently were severely crossed with at least one patient in a Phase II trial.

“We heard from multiple experts about the concerns this raises for treatment outside of clinical trials. Nearly everyone we spoke with discussed how MDMA breaks down barriers, heightens suggestibility, and creates a substantial risk with any therapists who might choose to take advantage of patients,” the report noted.

The institute found that one study participant reported an incident of sexual misconduct during a study session, in which the psychiatrist and her unlicensed therapist husband deviated from the study protocol to perform intimate physical contact with the participant during a distress episode, while she was in a mind-altered state under MDMA treatment.

“The participant also reported nonconsensual sexual relations occurring with the unlicensed therapist after the completion of the experimental sessions, but during enrollment of the trial. Due to concerns of participant safety and therapist compliance, the Phase II study was temporarily suspended to prioritize federal review of all trials involving MDMA,” ICER wrote.

That issue was also raised during the FDA Advisory Panel hearing and has been a topic that Lykos appears to prefer to play down.

ICER isn’t without its critics either, however. The group receives significant funding from insurance companies. Despite that, the institute’s value assessments can have a strong influence on pricing decisions for a product, according to the American College of Allergy, Asthma and Immunology.



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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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