Psychedelics

CLIENT ALERTS – PSYCHEDELICS AND MENTAL HEALTH THERAPEUTICS DEC 21, 2023 New Drug Application is a Major Milestone for Psychedelic-Assisted Therapy

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5 months ago

December 23, 2023

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MAPS PBC Submission for Approval of MDMA Is a First for Psychedelic-Assisted Therapy

On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) announced their submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine) in combination with psychotherapy for the treatment of post-traumatic stress disorder (PTSD).¹ This marks the first NDA submission for any psychedelic-assisted therapy and is a major milestone for the medicinal psychedelics industry.

MDMA, often grouped in the category of psychedelics, is a synthetic psychoactive compound classified as an entactogen — meaning it induces emotional states such as openness and oneness. Mental health professionals were already using MDMA in combination with psychotherapy to treat patients in the 1970s, but in 1985 the U.S. Drug Enforcement Administration (DEA) categorized MDMA (also known as ecstasy) as a Schedule I drug under the Controlled Substances Act precluding its medical use. In the 2000s, renewed interest in this compound led to a marked increase in investigational placebo-controlled studies of MDMA-assisted therapy for PTSD. In 2017, the FDA granted MDMA-assisted therapy for PTSD “breakthrough therapy” status — a designation designed to speed up the development and review of medications for serious conditions where preliminary clinical evidence has suggested the medication may show substantial improvement over available therapy on a clinically significant endpoint(s).²

MAPS PBC conducted six Phase 2 and two Phase 3 studies evaluating the use of MDMA-assisted therapy for PTSD. The two pivotal Phase 3 studies (MAPP1³ and MAPP2⁴) were randomized, double-blind, placebo-controlled trials in 90 and 104 subjects, respectively, with PTSD. Therapy involved three preparatory sessions followed by three treatment cycles over a three-month period with each treatment cycle including one medication session (where the patient self-administered MDMA under the supervision of a healthcare provider(s) who also delivered psychotherapy) and three integration sessions. Both studies met the primary endpoint measuring PTSD symptomology by the change from baseline to 18 weeks in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and a secondary endpoint of improvement in functional impairment associated with PTSD as assessed by the change from baseline to 18 weeks in the Sheehan Disability Scale (SDS). In both studies, no serious adverse events were reported in the group who received MDMA-assisted therapy.

In MAPS PBC’s press release, Amy Emerson, CEO of MAPS PBC, stated: “The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades.”⁵

MAPS PBC asked the FDA for priority review of their NDA. The FDA will decide within 60 days if the NDA will be accepted for review and if it will be a priority or standard review (six months or 10 months, respectively). An approval by the FDA of MDMA-assisted therapy for PTSD would also require the DEA to change the Schedule I classification of MAPS PBC’s formulation of MDMA so that it can be used as a prescription medication.

Many questions remain, such as, if approved, who will be allowed to provide MDMA-assisted therapy, whether the FDA will require a Risk Evaluation and Mitigation Strategy (REMS), and how much the MDMA-assisted therapy will cost or be reimbursed. As Amy Emerson stated: “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”⁶ Stakeholders in the medicinal psychedelic space see this NDA submission as a major milestone and a catalyst for the development and potential approval of other psychedelic medications. Healthcare facilities and mental health professionals interested in providing this therapy will likely need to begin planning in order to hit the ground running if MDMA-assisted therapy for PTSD gains FDA approval, as is expected.

Additional Assistance

For further assistance, please contact a member of our Psychedelics and Mental Health Therapeutics Practice Team or the Phillips Lytle attorney with whom you have a relationship.

¹ Press Release, MAPS PBC,MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD(Dec. 12, 2023),https://mapsbcorp.com/news/mdma-for-ptsd-fda-submission/.

² Press Release, MAPS,FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Therapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials(Aug. 26, 2017),https://maps.org/news/media/press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd-agrees-on-special-protocol-assessment-for-phase-3-trials/.

³ Jennifer M. Mitchell et al.,MDMA-Assisted Therapy for Severe PTSD: a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. 27 Nature Med. 1025, 1025-33 (2021).

⁴ Jennifer M. Mitchell et al.,MDMA-Assisted Therapy for Moderate to Severe PTSD: a Randomized, Placebo-Controlled Phase 3 Trial. 29 Nature Med. 2473, 2473-2480 (2023).

⁵ MAPS PBC,supranote 1.

⁶ Id.

Source: https://phillipslytle.com/new-drug-application-is-a-major-milestone-for-psychedelic-assisted-therapy/

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Psychedelics

Press Release: PsychedelicNewsWire Named Official Media Sponsor of the 4th Annual Psychedelic Therapeutics and Drug Development Conference

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2 days ago

May 18, 2024

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LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4^th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024

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individualized treatment

Risks of Psychedelics for People with Personality Disorders

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2 weeks ago

May 9, 2024

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While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert

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antidepressants

Treating Depression: Psychedelics vs. Antidepressants

Published

2 weeks ago

May 9, 2024

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Recent research suggests that psychedelics and traditional antidepressants, while both potentially effective in treating depression, work through distinct mechanisms. Understanding these differences could lead to more personalized and effective treatment approaches. Psychedelics vs. Antidepressants: What are the key differences?

Unlocking the Mysteries of Depression Treatment: Psychedelics vs. Antidepressants

The quest for effective depression treatments continues to be a significant focus in mental health research. Traditional antidepressants, like selective serotonin reuptake inhibitors (SSRIs), have been a mainstay in treatment, prescribed widely despite varying efficacy among individuals and often accompanying unwanted side effects. In contrast, psychedelics have recently garnered attention for their rapid and enduring antidepressant effects observed in clinical trials.

A recent study has delved into the distinct mechanisms of action of SSRIs and psychedelics, illuminating how they uniquely influence the brain and potentially alleviate symptoms of depression. SSRIs primarily increase serotonin levels in the brain, which is believed to enhance mood and diminish depressive symptoms. However, this process can require several weeks to manifest noticeable effects, and not all patients respond favorably to SSRIs.

Conversely, psychedelics such as psilocybin, found in “magic mushrooms,” operate through a different mechanism. Research indicates that psilocybin’s antidepressant effects are not directly due to elevated serotonin levels. Instead, psilocybin is thought to promote neuroplasticity, the brain’s capacity to reorganize and form new neuronal connections. This heightened neuroplasticity may facilitate more adaptable thought patterns and an improved ability to process emotions, contributing to the rapid and sustained antidepressant effects seen in clinical trials.

Moreover, the study examined the role of the 5-HT2A serotonin receptor, a primary target for both SSRIs and psychedelics. While SSRIs inhibit this receptor’s activity, psychedelics activate it. Intriguingly, blocking the 5-HT2A receptor did not reduce psilocybin’s antidepressant effects, suggesting that its therapeutic benefits originate from other pathways.

Psychedelics vs. Antidepressants: Why It Matters?

Understanding the distinct mechanisms by which psychedelics and antidepressants affect the brain is crucial for the development of more personalized and effective treatment strategies for depression. This knowledge could lead to enhanced patient selection for specific treatments, reducing trial and error while optimizing outcomes. Furthermore, exploring the unique properties of psychedelics may pave the way for novel antidepressant medications that are quicker acting and have fewer side effects.

Potential Implications

This research could catalyze a shift in depression treatment paradigms, moving from a one-size-fits-all approach to more targeted therapies. By pinpointing the specific mechanisms that underlie different antidepressant interventions, clinicians can customize treatment plans based on individual patient profiles and needs. This personalized approach could improve treatment success rates and enhance the quality of life for individuals battling depression.

What Next?

While the study of psychedelics for therapeutic purposes is still in its nascent stages, the initial findings are promising and suggest that psychedelics may offer a valuable addition to the arsenal of tools for combating depression and other mental health conditions.

Source: Neuroscience News

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