A European citizens’ initiative aimed at promoting psychedelic-assisted treatments for mental health disorders has been registered by the European Commission.

The initiative, dubbed “PsychedeliCare,” was registered on Sept. 11, according to the European Commission’s official website, in a bid to establish a transnational legal framework around psychedelic therapy in the union.

“The PsychedeliCare Initiative will be an amazing participatory democracy tool to put pressure on the EU to finally take action on the medical use of psychedelics,” Théo Giubilei, founder and organizer of the initiative, said on the group’s website.

The initiative proposes several objectives, including supporting “the establishment of an expert consensus on standards of psychedelic care, with psychological support, therapist training, ethical guidelines and safety measures.”

It also aims to boost “EU-funded research into the therapeutic applications of psychedelics to strengthen the evidence of their safety and efficacy,” and adopt “common positions within UN fora to advocate for pragmatic, progressive transnational regulations concerning psychedelic compounds.”

Organizers cited data from the Organisation for Economic Co-operation and Development (OECD) estimating the economic impact of mental illnesses at 4.2% of the EU’s annual GDP, or about 600 billion euros ($665 billion) per year. The group argues that up to 50% of patients do not respond to currently available psychiatric treatments.

“The EU has approved only one new psychiatric treatment in the last three years, in stark contrast to the 68 approvals in oncology,” the organizers said.

To succeed, the initiative must collect 1 million signatures within a year and meet minimum thresholds in at least seven EU member states.

“We call on the Commission to recognize the unique specificities of psychedelic therapies and their potential to meet high unmet needs for mental health conditions and substance use disorders,” the organizers said on the EU’s official initiative page.

The group noted that the U.S. Food and Drug Administration has already granted several breakthrough therapy designations for MDMA, psilocybin and LSD treatments.

Canada also allowed psychedelic-assisted therapy for end-of-life anxiety in 2022, while Australia recently authorized prescriptions of MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression.

The news follows the European Medicines Agency’s call earlier this year for psychedelic drug developers to target the EU market. The proposal also calls for the creation of a European hub for mental health R&D and the implementation of incentives to spur innovation in the field.

The PsychedeliCare organizers now have six months to start collecting signatures.

Psyence Biomedical Ltd (Nasdaq: PBM) is poised to hit several psilocybin-related “milestones” in coming months, including the acquisition of drug developer Clairvoyant, the launch of research into psilocybin as a treatment for substance use disorders and ongoing clinical trials in Australia for psilocybin in treating adjustment disorder.

CEO Dr. Neil Maresky shared details on the company’s ongoing moves in a shareholder update issued this week.

Psyence signed a conditional binding term sheet earlier this month to acquire Clairvoyant in an all-stock deal reportedly worth $500,000. Clairvoyant has its own clinical trials underway to evaluate psilocybin as a treatment for alcohol use disorder, with topline data expected in the second half of next year.

Maresky wrote that the acquisition “makes strategic sense for Psyence” because it runs parallel to Psyence’s own aims of mainstreaming psilocybin.

The acquisition also “expands our pipeline into AUD – a high-value indication – with a regulatory pathway that, if successful, will transition us to a commercial-stage, revenue-generating company,” he wrote.

The deal also connects directly to a business opportunity Psyence was eyeballing: substance use disorder treatment. The company has also been organizing new research into how psilocybin can be used to help patients with alcohol use disorder or other drug problems, and has signed a deal with Psylabs for “highly purified psilocybin extract” to be used in research.

“Numerous prior academic studies suggest that psilocybin, when combined with psychotherapy, can be a safe and effective treatment option for these individuals (with substance use disorder) – something that we aim to confirm in rigorously designed clinical studies,” Maresky wrote, noting there were 44 million people in the U.S. alone diagnosed with the ailment in 2021.

Psyence is also busy recruiting patients for an upcoming Phase 2b clinical trial in Australia for adjustment disorder treatments with psilocybin, from which it hopes to get topline data late next year that will support Phase 3 clinical trials. Those trials are being done in partnership with Fluence and iNGENū CRO Pty Ltd, and are evaluating two doses of naturally grown psilocybin, one at a 10 milligram dose and another with 25 milligrams.

To that end, Psyence also signed a supply contract with Canada-based Optimi, which ships naturally grown psilocybin and extracts all over the globe for medical research and treatments.

Psyence, which is still pre-revenue and working to bring psychedelic treatments to market, went through a merger in the spring to get uplisted to the Nasdaq from the Canadian Securities Exchange, and it appears the move has paid off.

Maresky wrote that in order to further the goals outlined in the update, Psyence has a “strengthened financial position” achieved by lining up “agreements that are expected to provide us with sufficient capital,” which may not have been possible without the Nasdaq.

However, the company has struggled to maintain the Nasdaq’s required Market Value of Listed Securities and Market Value of Publicly Held Shares. Last week, the exchange notified the Psyence Biomedical that it is at risk of being delisted. Psyence intends to request a hearing on the matter.

A recent U.S. Food and Drug Administration meeting on post-traumatic stress disorder treatments has reignited, within more official channels, the debate over the agency’s decision last month to delay approval of privately-owned Lykos Therapeutics‘ MDMA-assisted therapy.

The Sept. 6 hybrid public meeting, hosted by the Reagan-Udall Foundation for the FDA, drew experts, advocates and critics to discuss how to move forward advancing PTSD treatment. While the official agenda skirted the recent MDMA decision, public comments and a subsequent press briefing brought a spotlight back on the issue.

The FDA’s decision last month sent shockwaves through the psychedelic therapy community. Many close to the issue, including Multidisciplinary Association for Psychedelic Studies (MAPS), have continued to tout that MDMA-assisted therapy had shown promising results in clinical trials with PTSD patients.

Dr. Michael Mithoefer, former senior medical director at MAPS Public Benefit Corporation, said in a follow-up press briefing with reporters that “about two-thirds of people lost the diagnosis of PTSD” after treatment.

Despite so, the FDA ended up requesting more information before granting approval for Lykos’ proposed new drug, a move that has drawn criticism from various groups. Participants on the Friday FDA meeting call didn’t mince words during the public comment period.

“In my opinion, the FDA’s review of MDMA-assisted therapy failed,” said Dr. Robert M. Grant, a professor of medicine at the University of California, San Francisco. Grant has served on FDA advisory committees for four new drug applications and is trained in MDMA-assisted psychotherapy.

Grant said the agency “provided inconsistent guidance, did not adhere to previously given instructions, and did not offer context to its external advisors.”

He also stressed the “critical” need for better PTSD treatments, noting that “existing therapies reach less than 5% of the impacted population.”

Regarding the clinical trials, Grant defended the methodology used, saying he believed that the use of “blinded adherence raters as a primary outcome in MDMA trials is rigorous and best practice.” He added that alternative blinding methods suggested by critics “have been tried and rejected based on evidence.”

“The FDA missed an opportunity to provide clear guidance on how to move forward,” he said.

FDA call

The meeting’s official presentation largely avoided direct discussion of the MDMA decision, instead focusing on the wider scene for PTSD treatment and research, as well as the condition’s references in history’s past.

Dr. Paula Schnurr, executive director of the National Center for PTSD, declared on the call that the U.S. Department of Veterans Affairs is also “preparing for the potential future implementation of psychedelic treatments by supporting and conducting research on medications such as MDMA and psilocybin for treating PTSD and depression.”

She called psychedelic medicine “one promising avenue.”

However, the brief acknowledgments did little to address questions surrounding the FDA’s recent decision.

It was during the public comment period that the real-world impact of the FDA’s decision grabbed the spotlight. Veterans, PTSD survivors, and researchers took turns sharing personal experiences and expressing frustration with the delay in approving MDMA-assisted therapy.

The public comments painted the growing disconnect between the FDA’s cautious approach and more insistent needs expressed by potential beneficiaries of MDMA-assisted therapy.

“More than 150,000 veterans have died from suicide – 15 times the number killed in combat,” said Jesse Gould, founder of the Heroic Hearts Project. “This is a national crisis, and we need to act urgently.”

“Veterans are already traveling overseas for life-saving psychedelic therapies because they know these treatments work. The VA itself is running clinical trials on MDMA, and it supports these therapies. We cannot wait years for the FDA to catch up while more veterans die,” he added.

Others did not supported immediate approval, however. Dr. Nese Devenot, a senior lecturer at Johns Hopkins University with expertise in psychedelic bioethics, cautioned against lowering research standards or promoting false hope.

“Industry lobbyists have exerted pressure to lower these standards, and organizations funded by pharmaceutical companies have played a role in this push,” Devenot said. “The recent FDA decision to reject MDMA-assisted therapy came with new requirements, such as ensuring that any therapeutic adjuncts to drugs are evidence-based psychotherapies.”

Dr. Michael Abrams, a senior researcher with Public Citizen, defended the FDA’s decision. He cited concerns about unblinding bias in trials, lack of physiological data and the need to differentiate between drug and therapy effects.

“While these drugs clearly have powerful brain-based effects, evidence regarding their precise and safe actions in treating PTSD remains incomplete,” Abrams said.

“It’s important that psychedelic trials differentiate between the effects of the drug and the non-drug intervention, such as therapy. Both the drug and placebo groups in the MDMA trial showed positive effects, indicating that intensive talk therapy alone is beneficial. This offers hope for non-drug approaches as well,” he added.

The FDA, for its part, defended its stance.

“It’s essential that we collect data on the safety and effectiveness of these treatments because patients with PTSD, like all patients, deserve safe and effective options,” said Dr. Marta Sokolowska, deputy center director for substance use and behavioral health in the FDA’s Center for Drug Evaluation and Research.

MAPS’ follow-up call

While the FDA largely avoided direct discussion of the recent MDMA decision, a subsequent press briefing organized by MAPS circled in on the issue.

The FDA call, “illustrated the growing public interest in psychedelic-assisted therapies, with nearly every speaker discussing their potential in a meeting that wasn’t specifically about psychedelics,” according to Betty Aldworth, director of communications for MAPS.

Aldworth noted, “Eighty members of Congress, the Veterans Affairs Administration, trauma experts, patient advocates, and 14 of 23 stakeholders who gave oral testimony agree that the existing evidence base for psychedelic-assisted therapies merit widespread, and growing, support.”

Aldworth didn’t mince words about the impact of the FDA’s delay, and said, “It has been heartbreaking, not just for MAPS, but for the thousands of people still suffering from PTSD who have reached out to us, desperate for effective treatment.”

She claimed that the delay is pushing people towards the underground psychedelics market in search of medicine.

“Many people are using psychedelics in unregulated settings because they see them as their last chance to heal,” she said on the call.

Only two FDA-approved drugs for PTSD are available, and they are not effective for all patients, according to Dr. Bessel van der Kolk, a pioneering trauma researcher.

“MDMA helps people revisit dark places and say, ‘This happened, but it wasn’t my fault.’ Prozac doesn’t cause that,” he said on the call.

To another end, one researcher on the MAPS call stressed the need for more inclusive diagnostic criteria.

“The DSM-5 diagnostic criteria are highly suspect, especially when it comes to racial trauma,” Dr. Darron Smith said. “We need more holistic tools to evaluate healing and transformation, particularly for communities of color.”

MAPS outlined its next steps, including continuing Phase 3 clinical trials in addition to educating healthcare providers and policymakers. MAPS will also continue working with regulatory bodies, especially in states like Colorado and Oregon that are implementing their own regulated psychedelic treatment models.

“We are going to be putting a lot of our energies into the kinds of efforts that are going to provide access, regardless of what the FDA requires because the reality today is that many people are accessing these treatments,” Aldworth said.