As part of panel of experts convened by the U.S Food and Drug Administration (FDA), Case Western Reserve University professor Lee Hoffer voted last week to recommend a new nasal spray for treatment-resistant depression that some are touting as the most significant development in a generation for treating a disorder affecting more than 15 million Americans.
The medication is closely related to ketamine—a legal anesthetic with a history of recreational misuse. Packaging the drug esketamine in one-dose inhalers, the prescription would come with severe restrictions: only available in medical facilities and administered by licensed practitioners.
Citing studies showing the drug’s benefits outweigh its risks, Hoffer, an associate professor of anthropology in the College of Arts and Sciences and a professor of psychiatry at the School of Medicine, joined a 14–2 majority in recommending the medication for FDA approval (PDF).
The endorsement will be considered in the FDA’s March 4 decision on whether the drug should become available by prescription.
“People with severe depression do not have a lot of options, and existing antidepressants are limited in success,” said Hoffer, a temporary voting member of the FDA’s Drug Safety and Risk Management Advisory Committee.
“Many patients try a number of antidepressants that work temporarily, or not at all, and can have fairly extreme side effects,” said Hoffer, a cultural and medical anthropologist who researches illegal drug use, the misuse of prescription medications, and substance-use disorder. “This new medication shows promise for being an effective option for people with the worst of this condition.”
About a third of depression patients do not respond to treatment, according to the National Institutes of Health.
The Janssen Pharmaceutical Cos. of Johnson & Johnson is the drug’s manufacturer; the retail name of this form of esketamine is Spravato. As with any potentially addictive medication, the manufacturer must follow a risk evaluation and mitigation strategy for the drug.
“A lot of people I work with have addiction issues because of a drug that was prescribed to them,” said Hoffer, who researched recreational users of ketamine, ecstasy and other drugs common in party and club scenes in the late 1990s and early 2000s.
“It’s key that this medication would not be distributed to pharmacies,” said Hoffer. “Patients will not be taking it home—thus limiting the potential for abuse. It will only be administered in a controlled environment.”
The endorsement of the panel, which voted along with the FDA’s Psychopharmacologic Drug Advisory Committee, cited the medication’s promise as an acute treatment to help stabilize patients’ neurochemistry, or as part of a long-term maintenance regimen for major depression.
Data came from five Phase 3 trials in treatment-resistant depression patients, who had tried at least two other antidepressants without success, and other sources.
In 2017, Hoffer co-authored a National Academies of Sciences, Engineering, and Medicine report Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use; funded by the FDA, the findings provided the current data on the opioid crisis, pain management, and provided pain medication recommendations.
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