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Esketamine recommended by FDA panel

Posted by Hugh on February 13, 2019, at 10:04:48

Feb. 12, 2019
By Reuters

An experimental nasal spray, which has a compound similar to the 'club drug' ketamine, has been recommended as a new depression treatment by an advisory panel to the Food and Drug Administration Tuesday.

The influential panel voted 14-2 in favor of Johnson & Johnson's drug esketamine, a treatment developed to treat major depression in patients who have not benefited from at least two different therapies. The panel said the benefits of the nasal spray outweighed the risks. Side effects include dizziness, nausea and an unpleasant feeling of dissociation, according to the company. One member in the panel abstained from voting.

Esketamine is a variation of the anesthetic ketamine, which is also abused as a recreational party drug with the street name, Special K. Intravenous infusions of ketamine have been shown to help people with severe depression who experience suicidal thoughts, but the researchers expect the nasal spray will take effect more quickly and be easier to use.

"I think esketamine has the potential to be a game-changer in the treatment of depression ... I use the term potential because the issues of cost and patient accessibility need to be addressed," said Walter Dunn, a panel member who voted in favor of the approval.

The nasal spray acts quickly, showing benefits after four hours. The hope is that the spray can help the 30 percent to 40 percent of patients with major depression who don't respond to antidepressants, most of which take at least four weeks to take effect. Currently, Eli Lilly's Symbyax is the only FDA-approved drug for treatment-resistant depression.

Major depressive disorder (MDD) affects over 300 million people globally, and attempted suicides in people with this condition is about 20-fold higher than that of the general population, according to the company.

However, depression is a tricky area of development. Patients in clinical trials often show a big placebo response, masking the efficacy of the drug being tested.

The FDA, although not mandated to follow the panel's recommendation, is expected to announce its decision on esketamine by March 4.




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