#97: 💊 MDMA-AT Gets a No from the FDA
#97: 💊 MDMA-AT Gets a No from the FDA
FDA asks for more clinical trials
Hey Friends,
A long-awaited decision around MDMA-Assisted Therapy (MDMA-AT) was announced on August 9.
It was a No from the FDA - and I’m here to dive into the decision and what it means for the future of psychedelic therapy in this week’s Note.
If you want to catch up on other MDMA related Nina’s Notes check out the following:
#20: 🇦🇺 Australia Changes Classification Of Psilocybin & MDMA To Enable Prescription
#32: 💊 Why Does MDMA Cause a Hangover But Psilocybin and LSD Don’t?
#66: 🍄 Psychedelics As Potential Longevity Therapeutics
#67: 🥽 Using VR to Facilitate Psychedelic Therapy
#91: 👩🏽 Could MDMA-AT Have a Bigger Impact for Women?
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💬 In this note:
💊 MDMA-AT Gets a No from the FDA
📚 The Dark Forest
⚡️ The Exopulse Mollii Suit
💊 MDMA-AT Gets a No from the FDA
The US Food and Drug Administration (FDA) has decided not to approve Lykos Therapeutics’ new drug application for MDMA-assisted therapy (MDMA-AT) as a treatment for post-traumatic stress disorder (PTSD).
Although this is disappointing news for the psychedelic therapy advocates and veterans who have been fighting for this drug to help people with PTSD, it is not a complete surprise to industry insiders or Lykos itself.
The psychedelic therapy community has been bracing for this decision since June when Lykos received a negative decision from the FDA's Psychopharmacologic Drugs Advisory Committee after their review of the data from Lykos’ MDMA-assisted therapy clinical trials.
The advisory committee raised issues such as inadequate blinding of the participants, flaws in study decision and conduct, and ultimately voting that the therapies’ benefits do not outweigh the risks.
MDMA-Assisted therapy is the first of its kind to combine a psychedelic with assisted therapy.
The FDA does not regulate psychotherapy.
Therefore, the conversation around “is this a drug or a therapy” did not help Lykos win points with the FDA either.
This shows that attempting to win approval for a treatment that combines a drug with psychotherapy can be very difficult.
Lykos received a complete response letter (CRL) from the FDA denying the new drug application based on the data submitted.
The letter said that the issues raised by the FDA echo those brought up in the advisory committee meeting.
Now, the FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of MDMA.
The FDA needs to be very clear about what it expects of Lykos for the next round of trials to establish safety and efficacy.
It is not currently clear how much time and money it will take to satisfy the additional Phase 3 trial request.
Lykos also said that it will request a meeting with the FDA to ask for reconsideration of the decision and to discuss a resubmission.
Lykos and its parent organization, the Multidisciplinary Association of Psychedelic Studies (MAPS), has been working for decades toward winning the FDA approval for MDMA.
Scientific journal retracts papers on MDMA-assisted therapy
Following the rejection from the FDA, the journal Psychopharmacology retracted three papers on MDMA-assisted psychotherapy, involving authors affiliated with MAPS and its spinout Lykos Therapeutics, due to “protocol violations amounting to unethical conduct.”
This reason is particularly related to a Phase 2 trial where an unlicensed therapist was accused of sexual assault.
While misconduct in healthcare is not unique to psychedelic therapy, I do hope that not only psychedelic trials are held to this high standard of ethics and accountability, but all trials and healthcare practice are held to the same standards.
Other Psychedelics in Clinical Trials
Despite the FDA rejection of MDMA-AT, other psychedelics companies are moving ahead with their psychedelic candidate molecules.
On August 13, 2024, Atai Life Sciences reported their early data from its Phase Ib trial testing an oral form of the psychedelic DMT for treatment-resistant depression.
Atai is now preparing to launch a Phase 2 trial of their DMT drug to treat depression and the trial will exclude patients who are also doing psychotherapy.
Atai decided to isolate the effect of the drug as much as possible, as they believe that looking at the psychedelic drug on its own, rather than in combination with psychotherapy may make FDA approval more streamlined.
Some companies are using psychedelics purely as drug therapy, rather than to assist psychotherapy, including two companies aiming to treat depression with psilocybin.
Compass Pathways has two ongoing phase 3 trials, and the Usona Institute, announced the start of its Phase 3 trial in May 2024.
Mindmed, who completed a Phase 2b clinical study of LSD for anxiety also emphasized that it does not include a psychotherapeutic component.
While this may be the path for a more streamlined approval, I believe that psychedelics in combination with psychotherapy will lead to the greatest effects and integration of the learnings uncovered in the psychedelic experience.
I believe that giving someone a psychedelic and then expecting them to process all of the insights on their own is putting a big responsibility on the patient, who is already doing a tremendous amount of work by seeking psychedelic intervention for their depression, anxiety or PTSD.
If this next wave of applications has more success with the FDA by excluding the psychotherapy component, then I do hope that some companies still pursue a rigorous study of psychedelics combined with psychotherapy.
📚 Book of the Week
The Dark Forest by Lui Cixin
Rating: ★★★☆☆
The Dark Forest is the sequel to The Three-Body Problem (Nina’s Notes BOTW #81), and the second book in the trilogy.
This one was much more difficult for me to stay engaged with in comparison to Three-Body Problem.
The Dark Forest starts off slow, painfully slow in fact, and honestly does not pick up much until the very end.
Hard to imagine that the same author wrote Three-Body Problem which is super fast-paced.
The Dark Forest has several plot lines and sometimes it’s hard to follow or see the point in the side stories.
The last 100 pages are the best, with a battle between an alien probe and a starship fleet.
If you pick this one up, you can skip Part I and start right at Part II.
I’m very interested to see how Netflix adapts this second book as they confirmed that the sci-fi drama will return for Season 2 and Season 3.
⚡️ Check This Out
The Exopulse Mollii Suit by Ottobock can improve mobility for people affected by a stroke or Parkinson's disease.
Ottobock is a market leader in technical orthopedics.
Check out the suit in action in this instagram post.
The Mollii suit consists of a pair of trousers, a jacket and a detachable control unit that sends electrical signals to the user via electrodes on the inside of the garment.
The suit has 58 electrodes that can be combined in different ways and a control unit that is individually programmed for each user.
A computer program is used to program the suit, and it can adjust the active electrodes, the intensity and which muscles are to be activated with current.
According to the manufacturer it should be easy to use the device at home.
Edited by Wright Time Publishing