Regulator approves U.S. registration application for nasal spray to treat depression

The US Federal Drug and Food Administration (FDA) has approved the application for registration of the first and only nasal drug for the treatment of depression in adults. This was announced by Johnson & Johnson on Tuesday, January 21.

The spray will be prescribed to adult patients who have had an inadequate response to at least two oral antidepressants. The drug is based on ketamine (an anesthetic with hallucinogenic properties, banned by the Federal Drug Control Service. - Ed.).

"Therapy-resistant depression can be very challenging, especially for patients who do not respond to or tolerate oral antidepressants. For too long, providers have had few options to offer patients much-needed symptom improvement," said Global Therapeutic Area Head, Neurology, Johnson & Johnson Innovative Medicine Dr. Bill Martin.

The approval, granted after priority review by the FDA, is backed by positive results from a randomized, double-blind, multicenter, placebo-controlled study.

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Earlier on October 14, Bartosz Arlukowicz, a member of the European Parliament (EP) from Poland, said that there is a shortage of critical medicines in the European Union (EU). For example, it is difficult to find drugs for chronic and cancer diseases, painkillers and drugs for rare diseases. This leads to delays in treatment and increased patient mortality.