Ketamine-Based Antidepression Nasal Spray Gets FDA Thumbs Up

Ketamine-Based Antidepression Nasal Spray Gets FDA Thumbs Up

Ketamine-Based Antidepression Nasal Spray Gets FDA Thumbs Up

Ketamine is a mixture of two enantiomers (mirror image molecules), and this is the first FDA approval of esketamine for any use.

Some 16 million people in the USA have major depression, and one-third of them have not responded well to available treatments and may therefore be considered to have treatment-resistant depression. Agency approval came with a Risk Evaluation and Mitigation Strategy (REMS) to restrict esketamine to certified treatment centers where patients are monitored for 2 hours, prohibit it from being dispensed directly to patients, and enroll patients in a registry.

Data so far indicates that esketamine is safe to use, "but it has to be used in a very well-regulated way to prevent issues related to addiction/substance use", Dr. Hwang says. Sage Therapeutics (NASDAQ:SAGE), for example, revealed in January that its drug, SAGE-217 met primary and secondary endpoints in a Phase 3 clinical trial to treat postpartum depression.

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A clinical trial patient known as Robin P said the drug had a positive impact on him.

The list price of a drug is not necessarily what patients actually pay. Ketamine was approved for use as an anesthetic in the 1970s.

And as a growing number of studies have shown ketamine's effectiveness against depression, ketamine clinics have sprung up around the United States. In a long-term study, patients in stable remission taking the medication who continued treatment with the medicine were 51% less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.

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For the past 10 years, Papolos has been prescribing an intranasal form of ketamine for children and adolescents who have a disorder that includes symptoms of depression. The spray has been approved as an alternative for people resistant to other types of treatments.

The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression.

But he hopes that doctors who are now using ketamine continue to do so. "It'll be a lot less expensive and a lot easier for their patients [than esketamine]", he said.

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Esketamine seems to help alleviate depression by acting on the NMDA/glutamate receptor, which is different from more recently popular antidepressants. During the first month, patients will be treated twice a week. J&J priced the drug at a wholesale acquisition cost of $590 to $885 per treatment session, depending on which dose patients receive. Additional treatments will be provided on a weekly or biweekly basis.

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