FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression

A vial of ketamine. Launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now finding new life as a treatment for depression and suicidal behavio

A vial of ketamine. Launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now finding new life as a treatment for depression and suicidal behavio

All patients will be enrolled in the Spravato REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine. Johnson & Johnson is hopeful that this drug will be approved by hundreds of centers within the first year.

Spravato, an esketamine-containing nasal spray developed by Johnson & Johnson, was tested for use with oral antidepressants as a therapy for treatment-resistant depression. The medication will be marketed under the name Spravato.

In the longer-term maintenance-of-effect trial, patients who continued the use of Spravato experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray and oral antidepressant.

For some patients who have searched for a depression treatment for years, the results of ketamine treatment have been profound.

When the drug works, its effect is nearly immediate. To lower the risk, the FDA said that the drug will only be available in certified clinics where medical professionals can monitor patients.

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Now available anti-depressants such as Eli Lilly and Co's Prozac work on neurotransmitters like serotonin and norepinephrine, but most drugs take at least four weeks to show effect and fail to produce an adequate response in about 30 percent to 40 percent of patients with major depressive disorder (MDD). It is estimated that approximately one-third of U.S. adults with MDD have TRD. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments". 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.

So strict will be the conditions of use around Spravato that patients will only be able to administer the nasal spray inside their doctor's office and will not be able to take the medication home with them.

The anti-depressants available at present of the likes of Eli Lilly and Co's Prozac impact the neurotransmitters - serotonin and norepinephrine. 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.

Spravato is produced by Janssen Pharmaceuticals, based in Belgium. Levesque says the effect will wear off after a few weeks depending on the patient.

Shares of Johnson & Johnson were up slightly following the FDA's approval, inching up 0.18 percent over the two-day trading period to close at US$139.09 on Wednesday (March 6).

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