It is the first new antidepressant to be approved in decades that works in an entirely novel way, the first antidepressant to come in nasal spray form, and the first to work in a very short time rather than in weeks or even months. When it works, the new drug takes effect nearly instantly. This spray is a chemical cousin of ketamine that has been used for decades as an anesthesia for surgery patients.
The treatment comes with a boxed warning - FDA's harshest - flagging the risk for sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts after administration of the drug.
Spravato will cost between $590 and $885 per treatment. "The threshold has been two adequate and well-controlled trials".
The Anxiety and Depression Association of America, based in Silver Spring, Maryland, urged the FDA's approval to address what has been called one of psychiatry's most glaring problems. Traditional antidepressants make serotonin, a chemical that contributes to a person's overall happiness and well-being, available in the brain. 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.
Approval of the drug, which will be sold by J&J as Spravato, gives a new treatment option for individuals who have previously failed two or more antidepressants, a population that is estimated to account for roughly a third of the 16 million adults in the US who have had an episode of major depressive disorder. Side effects may include sedation and dissociation, and as such patients are required to stay with a professional caretaker for two hours after taking the medication.
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Spravato is a form of ketamine, originally approved in the 1970s and used as an anesthetic.
The FDA has more about this approval.
During the induction phase of the therapy, which lasts for a month, patients will be treated twice a week with either dose, resulting in a wholesale acquisition cost or list price in the range of $4,720 to $6,785, Janssen spokesman Greg Panico said in an email statement. "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".
The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression.
Patients will inhale the drug under supervision at these centers once or twice a week.