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Hope on the horizon for 2024 FDA approval of MDMA therapy



Hope on the horizon for 2024 FDA approval of MDMA therapy
Photo by Ishan @seefromthesky on Unsplash

MAPS PBC has published anticipated results from its Phase 3b study that could bring MDMA-assisted therapy closer to Food and Drug Administration (FDA) approval by 2024

Phase 3b (MAPP2) study results have shown that 71.2% of participants who received MDMA-assisted therapy no longer met the criteria for post-traumatic stress disorder (PTSD) at the end of the study.

Published in Nature Medicine, the second, confirmatory Phase 3 trial of MDMA-assisted therapy for PTSD met both primary and secondary endpoints, confirming the first Phase 3a (MAPP1) study findings. MAPP1 findings demonstrated that 67% of participants in the MDMA group no longer met diagnostic criteria for PTSD at the end of the study versus 32% of participants in the placebo group.

MDMA-assisted psychotherapy was granted a Breakthrough Therapy status in 2017 – despite being placed under Schedule 1 of the Controlled Substances Act (CSA) in 1984 – as increasing clinical research is showing the treatment’s efficacy for PTSD. 

The substance was often used during psychotherapy before its prohibition, and following the drug’s ban, MAPS began its pioneering clinical research with MDMA therapies in 1986 – with the goal of “developing MDMA’s therapeutic potential through FDA-approved protocols”.

Almost 40 years later, this latest Phase 3 study from MAPS Public Benefit Corporation (PBC) – MAPS’ wholly-owned subsidiary focused solely on completing MAPS’ clinical research – provides the FDA with the data it needs to consider the therapy’s approval. 

“Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPS-sponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024,” commented Rick Doblin, PhD, MAPS Founder and President, in a statement. 

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Nature Medicine has published the results of the second MAPS-sponsored Phase 3 trial of MDMA-assisted therapy for PTSD, confirming our prior results. 

“We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year — and that our Open Science, Open Books principle will inspire researchers to make this just the first of many psychedelic-assisted therapies to be validated through diligent research.”

A new option for patients

PTSD currently affects up to 13 million people across the US and around 7.7 million people across Europe, however, many treatments are ineffective – creating an urgent need for innovative treatments. The condition is often coupled with conditions such as anxiety, depression and addiction.

“With two positive Phase 3 studies published, we are focused on pulling all of the data together to submit the new drug application for MDMA-assisted therapy to the FDA later this year,” stated Amy Emerson, CEO of MAPS PBC in a press statement.

“Given the urgent need for novel effective treatment options for PTSD and with consistent results from two positive Phase 3 trials we are hopeful that MDMA-assisted therapy, if approved by the FDA, could be a new option for patients, providers and therapists to consider.”

The MAPP2 study results showed that participants in the MDMA-assisted therapy group experienced a significant reduction in PTSD symptoms versus participants receiving placebo with therapy.

The data also demonstrated that MDMA-assisted therapy significantly reduced clinician-rated functional impairment, and no serious adverse events were reported in either the MDMA group or the control group.

In its statement, MAPS highlights that the MAPP2 population reflects the PTSD demographic, with approximately half of the study participants identifying as racially or ethnically diverse.

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“MAPP2 data confirm the findings from MAPP1 suggesting the results may be generalised to a broader population of individuals with PTSD who vary not only in the severity of their symptoms, but also in their racial and ethnic backgrounds,” stated Jennifer Mitchell, Ph.D., Professor of Neurology and Psychiatry & Behavioral Sciences at UCSF, and Associate Chief of Staff for Research and Development at the San Francisco VA Medical Center. 

“The peer-reviewed publication of MAPP2 confirming the results seen in the first Phase 3 study helps validate the rigour of the data that we have collected in the pivotal programme.”

Cody Shandraw, CEO of Healing Commercial Real Estate Inc. (Healing CREI) and Managing Partner of Ambria Capital stated: “Witnessing this new milestone in MAPS’ clinical trial journey fills us with an overwhelming sense of excitement and anticipation. The years of dedication and hard work that have gone into reaching this point are truly inspiring. As we eagerly follow the progress of MDMA treatments for PTSD, we are reminded of the potential impact these advancements could have on improving lives across the world.

“Because of the global need for these innovative therapies, we anticipate that the demand from patients for this lifesaving treatment will necessitate 16,000 new clinics in the US to support MDMA therapy by 2031. This means that in order to make these treatments accessible to the patients that need them, the work must begin now to enhance the infrastructure within the US Healthcare system to ensure medical facilities across the country are designed to effectively deliver this new treatment option.

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“This achievement by MAPS is a testament to the collaborative efforts of the entire team and serves as a beacon of hope for the future of healthcare.”

The study was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and administered by MAPS PBC, which the non-profit says will now be compiling data from 18 MAPS-sponsored Phase 2 and Phase 3 studies to form the basis of the New Drug Application.

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Psilocybin analogue shows positive results in Phase 2 depression study



Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

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Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research



Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

Mental health research provider Clerkenwell Health is calling for volunteers to join its groundbreaking clinical trials that will research whether psychedelics can provide effective treatments for complex mental health conditions.

Clerkenwell is seeking a diverse group of volunteers from across the UK between 18 and 65 years old to take part in the trials if they suffer from a relevant condition. 

The trials, which will be conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, are being run in partnership with a number of world-leading drug developers to test whether psychedelic drugs – often combined with talking therapy – can offer a new approach to treating a variety of mental health illnesses.

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Clerkenwell Health is seeking volunteers for trials that look to find cures for a range of conditions, including PTSD, depression, alcohol use disorder and anorexia. 

Many of the conditions have few successful treatment options and Clerkenwell’s innovative methods of combining psychedelics with therapy aim to to treat these problems more holistically, providing long-term quality of life for patients.

Chief Scientific Officer at Clerkenwell Health, Dr Henry Fisher, said: “With the current system for treating mental health disorders simply not working, we’re calling for patients to help identify the next wave of treatments. 

“These have the potential to be groundbreaking for the millions of people across the UK who are affected by poor mental health.

“The status quo for mental health treatment has not only resulted in patients experiencing debilitating side-effects, huge waiting lists and high relapse rates, but is costly, complicated and broadly ineffective. 

“By participating in upcoming clinical trials, patients have an opportunity to make a valuable contribution to growing research which will support the development of the next generation treatments for mental health conditions.”

According to MIND, approximately 1 in 4 people in the UK will be affected by a mental health condition each year and with a significant rise in people contacting mental health services in recent years, there has never been a more desperate need to identify new and innovative treatments.

Given the challenges facing the country’s health service and with mental health challenges on the rise, the search for volunteers to test effective treatments has never been more pressing. 

Clerkenwell has stated, in this regard, that it has gone national with its search for volunteers in an effort to deliver medical breakthroughs in mental health akin to the Polio clinical trials in the 20th Century.

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Paper explores extended difficulties following psychedelic trips



Paper explores extended difficulties following psychedelic trips

A new paper has explored the extended difficulties experienced by some people following psychedelic drug use and discusses psychedelic harm reduction.

While multiple studies have shown that psychedelics can be safe when administered appropriately, some people experience difficulties following their use. These difficulties can last anywhere from a few days to years.

With a rise in clinical research surrounding these compounds, there is a drive to change drug policy and several places have already implemented progressive approaches to accessing these therapies such as decriminalisation or including them on authorised medical access schemes. 

In light of these developments, it is vital to understand the potential risks associated with psychedelic use and what actions can be taken to reduce these risks.

The paper has been published in Plos One and authored by a team of leading psychedelic scientists from the Universities of Exeter, Greenwich and Queen Mary, University College London and Royal Holloway, New York University and the Perception Restoration Foundation.

Extended difficulties following psychedelic use

The team of researchers has gathered data on the context of use, nature and duration of these difficulties and explored risk factors and perceived causes that may contribute to these experiences. 

The most common forms of extended difficulty that the team uncovered include symptoms such as anxiety/fear and existential struggle, as well as social disconnection, depersonalisation and derealisation.

“For approximately one-third of the participants, problems persisted for over a year, and for a sixth, they endured for more than three years,” the authors write.

The findings revealed that the length of time these experiences last following psychedelic use could be predicted by the participants’ knowledge of dose and drug type, and that the experiences were shorter if a participant had taken part in a guided psychedelic experience. 

Additionally, the most common length of time such difficulties lasted was between one and three years. When asked about mental illness onset following the psychedelic experience, 18.8% said they had gone on to be diagnosed with a mental illness, while 76.8% said they had not.

The authors write: “Our findings support the results of Simonsson et al., who found that anxiety was the most common enduring difficulty, based on quantitative questionnaire data and Bouso et al’s study of the Global Ayahuasca Survey, in which ‘feeling nervous, anxious or on edge’ was the second most common adverse mental health effect. Our findings also suggest that a Sense of disconnection from others was within the top five most prevalent themes, as did the studies by Simonsson et al. and Bouso et al. 

“Some extended adverse effects that were quite common in other studies weren’t so common in our data set–for example, feeling a harmful connection to the spirit world was reported by 14% of respondents to the Global Ayahuasca Survey but by less than 4% of our data set, which may suggest some forms of difficulty are particularly associated with certain psychedelic substances and/or their associated cultures.”

Reducing risk factors

The authors suggest a number of actions that could be taken to reduce these risks.

Highlighting that, as anxiety and fear are some of the most commonly reported difficulties, the authors suggest that all legal psychedelic experience providers give guidance on methods for “self-soothing and overcoming bouts of anxiety following the retreat, clinical trial or ceremony.”

Further suggestions include informing participants of potential harms and risks and advising participants that the integration process may take some time, and what practices can be done to help people cope with difficulties. The authors say these practices will be explored in an upcoming paper.

The team writes: “We envisage using the information in this study, and accompanying future papers that focus on social support and forms of coping used by those with enduring difficulties, to provide structured guidance and training to psychedelic retreats, therapists and clinical trial centers about the potential for adverse experiences, what the potential risk factors are and what can be done to help individuals who report such extended difficulties.”

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