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VA to offer new ketamine-based nasal spray to help combat depression

VA to offer new ketamine-based nasal spray to help combat depression

Editor’s Note: This article by Patricia Kime originally appeared on Military.com, a leading source of news for the military and veteran community. The newest FDA-approved medication to treat severe depression, a nasal spray based on the anesthetic (and misused hallucinogenic party drug) ketamine, will soon be available to veterans treated within the Department of Veterans Affairs. In a […]

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Robert Pollack, MD Certified in Spravato REMS

Robert Pollack, MD Certified in Spravato REMS

Robert Pollack, MD has been certified in the Restrictive Program called Spravato REMS (Risk Evaluation and Mitigation Strategy) for the administration and monitoring of Spravato, the newly released Intranasal formulation of Esketamine for the treatment of TRD (Treatment Resistant Depression). Janssen announced that they received FDA approval for this medication February 5 , 2019. For […]

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FDA panels back intranasal esketamine for refractory depression

FDA panels back intranasal esketamine for refractory depression

Each disposable intranasal delivery device contains 28 mg esketamine; it will come in prepackaged units of one, two, or three devices to deliver the prescribed doses of 28 mg, 56 mg, or 84 mg, respectively. The device does not require priming and, after use, contains only about 30 microliters of residual medication. Its interlocking design, […]

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FDA Committees Vote on Esketamine Nasal Spray for Treatment-Resistant Depression

FDA Committees Vote on Esketamine Nasal Spray for Treatment-Resistant Depression

The Food and Drug Administration (FDA)’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor (14 yes, 2 no, 1 abstain) of the approval of esketamine nasal spray (Spravato; Janssen) for the treatment of adult patients with treatment-resistant depression (TRD). The decision was based on data from five Phase […]

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Esketamine Evaluated in MDD Patients at Imminent Risk for Suicide

Esketamine Evaluated in MDD Patients at Imminent Risk for Suicide

Janssen announced new findings from a Phase 2 study evaluating esketamine nasal spray in patients with major depressive disorder who were at imminent risk for suicide. The findings were published in the American Journal of Psychiatry. Esketamine nasal spray is an investigational glutamate receptor modulator that is thought to help restore synpatic connections in brain cells in patients […]

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Intranasal Esketamine Evaluated in Treatment-Resistant Depression

Intranasal Esketamine Evaluated in Treatment-Resistant Depression

(HealthDay News) — Esketamine seems to be efficacious and safe for patients with treatment-resistant depression (TRD), according to a study published online Dec. 27 in JAMA Psychiatry. Ella J. Daley, M.D., from Janssen Research & Development LLC in Titusville, N.J., and colleagues conducted a phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study to examine the efficacy, […]