Sorry, You Probably Cannot Get MDMA Through Telehealth

By Vincent Joralemon

The U.S. Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly.” 

Yet, once approved, FDA will put limits on the approved drug. If past psychedelics are any indication, this means that MDMA will probably need to be provided in a clinic under certain protocols. This means patients will need to wait for other MDMA products to complete clinical trials before we’ll see at-home, private use of the drug.

The MDMA NDA

Back in December 2023, Lykos Therapeutics (formerly MAPS PBC) submitted a New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), which FDA recently granted priority review. That application includes Lykos’ two Phase 3 studies and several other trials; these results were strong enough that many experts expect FDA to approve the application sometime this year.

If approved, DEA rescheduling will probably follow; allowing many Americans legal access to MDMA for the first time. Yet, just because MDMA will become legal for some does not mean it will be widely available to all those seeking access. To explain why, we first have to get a bit into FDA regulations.

Off Label Prescriptions

First, we’ll start with another psychedelic that you can currently get over telehealth: ketamine. In my last post, I gave a bit of background on off-label ketamine prescriptions:

Ketamine is unique among psychedelics because it is a Schedule III narcotic… This is because ketamine was developed, and is still widely used, as a human anesthetic. So, physicians can also prescribe it “off label” for depression, anxiety, or any other indication they think it may alleviate. 

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The U.S. grants doctors broad discretion to prescribe medications off-label—so if a clinician believes ketamine will alleviate a patient’s depression or anxiety, they can prescribe it relatively easily.

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FDA approval for at least one indication is necessary for other “off-label” uses of the drug. You need one FDA approval to open the door to other off-label uses.

One of the easiest (and cheapest) ways to get off-label ketamine right now is over telehealth, which apparently requires as little as a 30-minute consultation for a prescription of the dissociative drug. Again, this is because:

(1) Ketamine is FDA-approved as an anesthetic;

(2) Drugs with one approved indication can be prescribed off-label for other indications; and

(3) The Ryan Haight Act allowed for Schedules II-V controlled substances to be prescribed over telehealth, without a prior in-person examination.

You might think: if ketamine is available, will MDMA also be available via telehealth soon? The short answer is: probably not. The long answer involves a fun journey into FDA risk mitigation strategies.

Risk Mitigation: REMS

The FDA Amendments Act of 2007 gave the agency new authority to restrict distribution and use of approved drugs through something called Risk Evaluation and Mitigation Strategies (REMS). When approving a new drug, FDA can attach a REMS if they deem it necessary to ensure the drug’s benefits outweigh its risks.

Ketamine, again, is illustrative here. Spravato is another ketamine-based drug, but it is a bit different from the ketamine available over telehealth. Spravato is a nasal spray of esketamine, a ketamine derivative that, by many accounts, is pretty similar to ketamine. Yet, when FDA approved Spravato in 2019, they did so with a REMS attached. The Spravato REMS mandated that it can only be dispensed at approved “Spravato Clinics,” specifically prohibiting dispensing these drugs directly to patients for at-home use. Therefore, you cannot get Spravato over telehealth.

Experts anticipate the Lykos MDMA will have a similar REMS attached. What exactly that REMS says, however, is tricky to guess. Lykos and FDA negotiate the terms of the REMS, which are included in the approved NDA. This creates a balance for Lykos — a more restrictive REMS increases their chance of approval because it shifts the risk-benefit calculation FDA takes into consideration before approving the drug. Yet, MAPS, Lykos’ parent nonprofit, is open about their desire to make MDMA available beyond the medical context; so a less restrictive REMS would translate to more access to a drug that is central to their mission.

Safe Use: ETASU

Under the REMS, FDA may also require “elements to assure safe use” (ETASU) of the drug. According to FDA, those may include:

1. That healthcare providers have particular training, experience, or certification;
2. Patients be monitored;
3. Patients be enrolled in registries;
4. Pharmacies and others dispensing the drug be specially certified;
5. The drug be dispensed to patients only in certain settings, such as hospitals; or
6. Documentation of “safe-use conditions” before dispensing.

This is a good time to note that Lykos’ FDA application has not been for MDMA alone. It is for MDMA-assisted therapy. Lykos’ clinical trials were all about a drug-therapy package deal, where PTSD patients take the drug with a MAPS/Lykos-trained clinician guiding them. Although some of the preparation therapy sessions in this protocol can take place via telehealth, when a patient actually takes MDMA, they do so in person, guided by a trained clinician. It seems likely that FDA and Lykos will attach that in-person clinical observation as a component of the ETASU. So, at-home, private MDMA use seems far away, for now.

Waiting for MDMA

There are several other barriers to an MDMA telehealth expansion, including off-label reimbursement barriers, advertising limitations, and hesitation from providers over DEA’s strict rules regarding Scheduled drugs for patients. Yet, to recap, the key reason MAPS’ MDMA-assisted therapy will likely not be available via telehealth or for at-home use is because Lykos’ current application is based on MDMA-assisted therapy, and FDA will almost surely require that patients take the drug in a clinical setting under the watchful eyes of a trained guide.

So, if you were looking forward to getting MDMA legally over the phone soon, you will probably have to wait a bit longer. I’ll note that there are several other MDMA therapies in clinical trials right now, including Tactogen’s Phase 2 MDMA + Citalopram PTSD study, MindMed’s Phase 1 R-MDMA Autism Spectrum Disorder study, and EmpathBio’s proprietary MDMA derivative PTSD study. One of those may include a less restrictive REMS that allows for telehealth prescriptions and at-home use. That will be interesting to see unfold.