March 20, 2019

FDA Approves Fast-Acting Nasal Inhaler Depression Drug

12 March 2019, 05:54 | Silvia Roy

FDA approves new Johnson & Johnson drug for depression

Ketamine-based drug approved for treating severe depression in the US

The drug is made by Johnson & Johnson and is marketed under the name Spravato.

The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants. 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. In all three, patients were started on a new oral antidepressant and randomized to receive Spravato or placebo in addition - a design that experts on the advisory committee indicated better reflected how the drug would be used in the real world.

"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Dr. Tiffany Farchione, acting director of the FDA's Division of Psychiatry Products.

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A mind-altering medication related to the club drug Special K won USA approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. It has been slated to cost around $885 (£673) per treatment. For Spravato, however, the agency agreed to consider a withdrawal, or maintenance, study as one of the two positive trials supporting J&J's application.

The FDA concludes the drug is also being tested in patients with depression who are at a high risk of committing suicide.

The nasal spray must be taken by patients under the supervision of a healthcare provider in a certified doctor's office or clinic and the spray can not be taken home. Like the ketamine sold legally for anesthesia, Spravato is a Schedule III controlled substance, along with opioid painkillers, due to the potential for abuse leading to dependence. Ketamine was approved for use as an anesthetic in the 1970s. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000. "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". But the FDA approval, he adds, is a step toward having another viable and safe treatment for major depression.

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Charney was part of the team that first showed two decades ago that ketamine could treat depression.

The list price of a drug is not necessarily what patients actually pay.

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.

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