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These knocks come as the Drug Enforcement Administration continues to craft a rule that would set new limits on how health-care professionals can use telemedicine to prescribe tightly regulated drugs like ketamine.
Ketamine has been used for anesthesia in hospitals for decades and illicitly as a club drug. In more recent years, it has shown promise as a salve for depression when conventional antidepressants have failed.
The FDA approved a derivative of ketamine, the nasal spray Spravato, in 2019. But the strict rules governing the use of Spravato have led many people to seek other ways of getting the drug that are legal but not FDA-approved. Clinics have sprung up to provide infusions, while some providers prescribe a tablet that can be taken at home.
The rapid expansion of ketamine out of health-care settings and into patients’ homes has heightened a debate among ketamine providers who see the drug as a critical tool for combating mental illness but disagree over how it should be used.
“This is a wake-up call for ketamine practitioners and the wider medical community to put clear and unified guardrails in place guided by real-world data and medicine,” the nonprofit American Society of Ketamine Physicians, Psychotherapists, and Practitioners said after ketamine was implicated in Perry’s death. The group pledged to create guidelines for using ketamine at home.
Many practitioners consider ketamine to be safe, with less potential for abuse than opioids. The FDA, however, hasn’t established dosing guidelines for ketamine when used for a psychiatric condition, and the agency flags safety concerns that include abuse, increases in blood pressure and bladder problems. Adding to the risk, the FDA says, is using the drug at home without a health-care provider present.
Despite such alarms, there is considerable excitement about the prospects for ketamine and other drugs with psychedelic properties to treat mental health disorders. Barely two weeks after the FDA’s warning, Beckley Waves, a venture company focused on psychedelics, bought telehealth ketamine firm Nue Life for terms that weren’t disclosed. Nue Life had been valued at $103 million as of 2022, according to data provider PitchBook. Mindbloom, a rival firm, had an estimated value of $230 million as of 2021, according to the service.
Nue Life has provided at-home ketamine therapy to more than 10,000 patients across 23 states, according to the deal announcement. Daniel Love, Beckley Waves co-founder, said “through Nue Life, we can provide affordable access to safe and legal ketamine therapy,” adding that the firm takes the risks seriously and is committed to strengthening safety protocols.
One major divide among ketamine practitioners is over how and where patients receive treatment. One camp insists the drug is safest and most effective when used in the presence of a trained therapist, while others argue that allowing patients to use it at home can provide more affordable relief from depression, anxiety and post-traumatic stress disorder.
Each approach has trade-offs. A trained therapist on-site can help a patient navigate the drug’s mind-altering effects and ensure physical safety, but that can be expensive. Signing up for a virtual service can be more accessible for some, though it doesn’t come with the same level of support as an in-person experience.
Raquel Bennett, a ketamine specialist and founder of the Kriya Institute, belongs to the former camp, seeing ketamine as a tool of self-discovery. “The goal of ethical ketamine treatment is not to have clients be dependent on ketamine forever,” she said, adding that if prescribers don’t help patients learn new emotional skills, “they may be contributing to creating ketamine addiction.”
A spokesperson for Mindbloom said it “has helped thousands of people overcome depression and anxiety,” and that its protocols “include extensive safeguards to ensure that treatment is effective and safe.”
The debate over using ketamine at home intensified during the pandemic, as Mindbloom, Nue Life and other start-ups capitalized on a federal waiver of a requirement that prescribers evaluate patients in person before treating them with DEA-regulated drugs. This meant that doctors could prescribe ketamine to patients from their computers, often treating people in multiple states.
In March, the DEA proposed a rule to govern how health-care professionals use telehealth to prescribe controlled substances — drugs considered to have varying degrees of potential for abuse. For drugs in ketamine’s classification, a doctor could prescribe a 30-day supply through a telehealth visit but a patient would need to be evaluated in person after that for the treatment to continue.
That prompted an avalanche of pushback from patients and providers who’ve come to rely on telehealth for controlled medications ranging from Adderall to benzodiazepines. Many said ketamine has been lifesaving for them. The DEA received more than 38,000 comments on its proposed telemedicine rule and a related rule for buprenorphine.
“We believe that is among the highest number of comments we have gotten in DEA’s history,” Anne Milgram, the agency’s administrator, said at a listening session in September.
Not all of those in favor of expanded access to telehealth think that ketamine should be a part of it. At the listening session in September, Georgia Gaveras, chief medical officer of Talkiatry, proposed that ketamine be excluded from the telehealth rule, pointing out that patients using Spravato have to be monitored by a health-care professional.
“We also believe that the at-home prescribing of a substance that does have huge promise for depression also has very significant diversion risks, and we believe that it should be regulated further,” she said, according to an event transcript.
Some pharmaceutical firms are betting they can improve on the generic ketamine that is prescribed off-label today.
Adam Kaplin witnessed the power of ketamine while overseeing clinical trials that led to the approval of Spravato, but also saw the inconvenience and cost that comes with the FDA-required monitoring. Events like Perry’s death, he said, show “it is a very potentially dangerous practice to give patients access to this at home.”
Kaplin, now chief scientific officer of Mira Pharmaceuticals, is aiming to develop a derivative of ketamine with fewer side effects. The goal, he said, is to create a drug that even the FDA will endorse as safe for patients to take at home.
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