Health Care

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

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

The drug, a nasal spray that manufacturer Johnson & Johnson has branded Spravato, is a close chemical relation to ketamine, an anesthetic that is known for its heady effects on the brain.

FDA approves Johnson & Johnson's Fast-Acting Depression drug for quick relief from mental depression is undoubtedly a great success for the acute patients. Prozac, like other anti-depressants, affects the brain chemical serotonin.

Prozac therapy can take weeks or months to become effective, but Spravato has an nearly immediate effect as it alters the neurotransmitter glutamate, according to researchers.

A mind-altering medication related to the club drug Special K won USA approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. "People are saying this is a game changer because it seems like it works well for refractory depression, meaning people who have failed to respond to conventional antidepressant medications and behavioral treatments", Soonjo Hwang, MD, a psychiatrist with the University of Nebraska Medical Center, tells Health.

According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session. 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.

Esketamine is related to ketamine, which is used for other purposes in medicine but is not approved by the FDA for treating depression.

The medicine will be available with a warning label that in some people, it can increase suicidal thoughts during the first few months of treatment or if the dosage is changed.

The FDA approval is a significant milestone not only for the company but for those living with MDD. Like the ketamine sold legally for anesthesia, Spravato is a Schedule III controlled substance, along with opioid painkillers, due to the potential for abuse leading to dependence.

The United States Food and Drugs Administration (FDA) have approved for sale a new nasal spray containing Esketamine for the management of treatment-resistantdepression.

During the one-month induction phase, treatment with Spravato would cost between $4,720 to $6,785. Side effects may include sedation and dissociation, and as such patients are required to stay with a professional caretaker for two hours after taking the medication.

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

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