FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake
(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Tuesday recommended Johnson & Johnson’s experimental nasal spray, which has a compound similar to often-abused ketamine, for patients suffering from depression.
The panel voted 14-2 in favor of the drug esketamine, developed to treat major depression in patients who have not benefited from at least two different therapies, saying its benefits outweighed the risks. 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 nickname Special K.
“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.
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.
About 30 percent to 40 percent of patients with MDD fail to respond to first-line treatments such as antidepressants, most of which take at least four weeks to take effect on the patient. Currently, Eli Lilly’s Symbyax is the only FDA-approved drug for treatment-resistant depression.
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.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta