That's about 5 million of the 16 million Americans with depression. Like any new medication, it comes with many questions; clinical studies before FDA approval are limited in the number and type of patient they include, meaning that more information only comes to light when new drugs reach the "real world". The drug, a nasal spray that manufacturer Johnson & Johnson has branded Spravato, is a close chemical relation to ketamine, an anesthetic that is known for its heady effects on the brain.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
Patients can only receive Spravato under the supervision of a health care provider at a certified clinic, who is required to monitor treated individuals for at least two hours after administration. Critics are anxious, however, that the drug will have a high potential for abuse, like its cousin ketamine.More news: OPPO Reno line may just be a flagship with 10x lossless zoom!
Esketamine, developed by Johnson & Johnson, will be administered as a nasal spray and be used in conjunction with an oral antidepressant. That means patients who have not responded to "at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode", according to the FDA. "The threshold has been two adequate and well-controlled trials".
A long term study of the drug showed that patients in stable remission taking the drug that continued the treatment were 51 percent less likely to relapse as compared to those who continuously took a placebo with an 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. In a briefing document released ahead of the advisory committee meeting, members expressed concern that because patients in one of the trials receiving Spravato at 84mg did not experience greater efficacy than those receiving 56mg, there may be insufficient evidence to say the higher dose yields a therapeutic dose response relative to its higher rate of adverse side effects. Spravato can't be taken at home.
A decades-old drug, ketamine is already used off-label to treat depression by some doctors.More news: Insult to Muslims to say Ramzan will affect voting: Asaduddin Owaisi
The list price of a drug is not necessarily what patients actually pay.
According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session.
During the one-month induction phase, treatment with Spravato would cost between $4,720 to $6,785.More news: The US urges Germany to reject Huawei's bid for its 5G network