Thursday, 21 March, 2019

Ketamine-like drug approved for severe depression

Ketamine-based drug approved for treating severe depression in the US FDA approves new Johnson & Johnson drug for depression
Celia Hoffman | 12 March, 2019, 17:55

The decision comes after an FDA advisory panel recommended approval of the drug, Spravato, which is created to treat depression in patients who have not benefited from two or more antidepressants.

The approval is in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them. Johnson & Johnson's new nasal spray contains the chemical mirror image of ketamine, which has previously been called a "party drug" because of its quasi-psychedelic effects.

The other two trials did not show statistically significant improvements over placebo.

"We know that for someone who has failed two traditional antidepressants, if you try a third of the now approved medications, there's a [small] chance to achieve remission", said Dunn, who served on an FDA advisory panel which recommended approval of Spravato last month by a vote of 14-2.

The treatment is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS), because of the risk of adverse outcomes resulting from sedation and dissociation. 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.

WASHINGTON | 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. To lower the risk, the FDA said that the drug will only be available in certified clinics where medical professionals can monitor patients.

More news: Westbrook has testy encounter with fans in Utah

Esketamine is the s-enantiomer of ketamine.

The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants.

According to Business Insider, the cost of the drug isn't cheap: the price tag ranges anywhere between US$590 to US$885 per treatment session, depending on how high of a dose a patient needs.

A decades-old drug, ketamine is already used off-label to treat depression by some doctors. Spravato can't be taken at home.

The pharma said it was working to educate and certify treatment centers for Spravato. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000. And they will receive a dose that is unlikely to produce side effects such as hallucinations. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months.

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