This is the first new depression treatment that has been approved by the FDA in over 30 years, but is highly controversial due to its chemical similarities to ketamine and the FDA's Boxed Warning on the treatment. That's about 5 million of the 16 million Americans with depression.
When the drug works, its effect is nearly immediate.
In the case of esketamine (sold as Spravato), one of these concerns is that it's related to ketamine, which has been used as an anesthesia and to get high in the form of the once-popular party drug Special K. There's a concern that this new antidepressant may carry a risk of addiction and substance abuse.
The drug will only be available through a restricted distribution system.More news: Windows 10 Can Now Automatically Roll Back Faulty Updates
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"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". Critics are anxious, however, that the drug will have a high potential for abuse, like its cousin ketamine. More recently, some doctors have given ketamine to people with depression without formal FDA approval. In the longer study, patients whose conditions had stabilized and continued to take the nasal spray in conjunction with an oral antidepressant took a "statistically significant longer time" to relapse than patients who received a placebo nasal spray with their oral antidepressant. Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder. Spravato can't be taken at home. "It will only be available in approved and certified treatment centers".
According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session. The health care provider will then observe the patient for treatment-emergent sedation, dissociation and blood pressure changes for at least 2 hours, until the patient is safe to leave. "It really has opened up a whole new way of thinking about depression", Gerard Sanacora, professor of psychiatry at Yale University School of Medicine and director of the Yale Depression Research Program, said of ketamine. A month of treatments - at two sessions per week - is estimated to cost $4,720 to $6,785, the pharmaceutical company said.
In an emailed statement, J&J said Spravato's list price is "generally comparable" with other specialty mental health drugs.