The Food and Drug Administration (FDA) recently approved a new prescription-only nasal spray for use against treatment-resistant depression. Fast-acting Spravato is for use in conjunction with an oral antidepressant in adults with treatment-resistant depression, notes the FDA.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”
Patients with treatment-resistant depression typically have had persisting symptoms of depression, despite at least two full treatment episodes with different antidepressants. For such patients the fast-acting nasal spray could present a breakthrough.
According to the New York Times, doctors welcome the new depression drug, albeit cautiously. Dr. Cristina Cusin directs the ketamine program at Massachusetts General Hospital in Boston. She told news station WBUR, “It’s a huge step to have the first molecule in 30-plus years—the first antidepressant approved that has a mechanism that is fundamentally different from what we have available now.”
Esketamine is a molecular variation of ketamine, which can alleviate symptoms of treatment-resistant depression in just a few hours. While ketamine has attracted criticism and controversy over the years, there are reasons to be cautiously optimistic about the efficacy of the new Spravato spray. Critics are worried that the drug has a high potential for misuse, comparable to its cousin ketamine. Both drugs can induce psychotic episodes in people who are at risk for them.
“Ketamine, first developed in 1962 as an anesthetic, has a storied experimental past, including as a combat-zone anesthetic and party drug known as ‘Special K.’ Arguing that the effects of ketamine were similar, but less intense than phencyclidine (PCP), the Drug Enforcement Administration, in 1999, classified ketamine as a Schedule III controlled substance,” writes psychologist Joan Cook on thehill.com.
The attempt to curb recreational use hasn’t stopped scientists from studying the drug, though, and advocates hope esketamine can now bring relief to the most desperate patients.