FDA approves new nasal spray medication for depression

Faith Castro
March 12, 2019

At present it is to be prescribed only in patients who have not responded to two other conventional antidepressants.

A drug inspired by the anesthetic ketamine - the first in decades to work in a completely new way in the brain. 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. It has been slated to cost around $885 (£673) per treatment. They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days. Traditional antidepressants make serotonin, a chemical that contributes to a person's overall happiness and well-being, available in the brain.

"I think we need to be cognizant of not positioning [Spravato] as a wonder drug or as a panacea, because it's not", said Steven Meisel, system director of medication safety at Fairview Health Services in Minneapolis, Minnesota, in an interview with BioPharma Dive.

One short-term trial that lasted four weeks determined that a combination of Spravato and an oral antidepressant demonstrated a "statistically significant effect" compared to a placebo.

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This could be fantastic news for a third of those who suffer major depressive disorders and who don't respond to existing therapies and it will only be administered to those for whom the existing treatments don't work. In a briefing document released ahead of the advisory committee meeting, members expressed concern that because patients in one of the trials receiving Spravato at 84mg did not experience greater efficacy than those receiving 56mg, there may be insufficient evidence to say the higher dose yields a therapeutic dose response relative to its higher rate of adverse side effects.

Patients can only receive Spravato under the supervision of a health care provider at a certified clinic, who is required to monitor treated individuals for at least two hours after administration. That means twice-weekly treatments during the first month will cost centers that offer the drug at least $4,720 to $6,785.

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University. He has researched ketamine and used it to treat depression. It did not, however, reveal the drug's list price.

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