For the first time in decades, the FDA has approved a new treatment for depression – and it has the potential to offer relief to millions of patients who have exhausted all other options.
The treatment is a nasal spray called esketemine, which is being marketed under the brand name Spravato. The spray will be prescribed alongside an oral antidepressant to adults who have developed treatment-resistant depression.
Most antidepressants on the market can take weeks, even months to take effect on a patient’s depressive symptoms. Additionally, these oral antidepressants often have little to no effect on a patient’s depression.
Spravato, on the other hand, is designed to relieve depressive symptoms within a matter of hours. That being said, the drug has received some controversy because it is a chemical variant of ketamine, an anesthetic which has historically been abused for recreational purposes in club scenes and party situations.
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It is for this reason that the spray can only be administered by health care professionals in a supervised clinical environment. It is also expected to be covered under most insurance plans.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, 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.”
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Over the course of the clinical trials, esketemine received “breakthrough” and “fast track” designations from the FDA. In a long-term clinical trial researching the drug’s effect on 1,700 adults with treatment-resistant depression, patients were 51% less likely to experience a relapse of depressive symptoms compared to those who were given a placebo and oral antidepressant.
In a short-term study, patients “experienced superior improvement in depression symptoms at four weeks, compared to those who received a placebo and an oral antidepressant.” Side effects included relatively minor symptoms, such as dizziness, fatigue, sedation, lack of energy, and spinning sensations.
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, the global head of Janssen Research & Development, LLC. “This unique and innovative medicine is a testament to our heritage of advancing solutions in neuroscience to heal minds and improve health outcomes.”
A 57-year-old patient who has struggled with depression throughout her life described her experience with the nasal spray to The New York Times, saying that her third and fourth infusions of the drug had a noticeable effect on her underlying mood.
“It’s a hard thing to describe,” she told the news outlet. “I was still anxious, but I felt somehow more solid, like something gelled within me, and my husband has noticed it, too.”
Another patient with treatment-resistant depression testified to the drug’s success in a statement announcing its FDA approval.
“It was hard to have any emotions, because I was just numb,” said the esketamine clinical trial patient. “When I began treatment with esketamine and my symptoms started to lift, I could see very clearly just how depressed I had been. I’m now able to appreciate a wider range of emotions than when I was depressed. My long-term goals have taken shape and actually seem attainable.”
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