FDA Okays Janssen's Nasal Spray Medication For Treatment-resistant Depression

(RTTNews) - Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration has approved SPRAVATO (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression or TRD.

People who are currently struggling with major depressive disorder (MDD) are considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.

It is estimated that approximately one-third of U.S. adults with MDD have TRD.

SPRAVATO carries a Boxed WARNING regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.

In clinical trials, the most common side effects of SPRAVATO when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.