J&J's Spravato Meets Primary Phase 3 Endpoints in Imminent Suicide Risk

By Colin Kellaher

Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit on Monday said a pair of Phase 3 studies of its Spravato nasal-spray treatment for depression met their primary endpoints in adults at imminent risk for suicide.

The drug maker said Spravato in addition to standard of care showed clinically meaningful and statistically significant superiority in the reduction of depressive symptoms at 24 hours after the first dose in adults with major depressive disorder who have active suicidal ideation with intent.

Janssen said the onset of effect for currently available antidepressants can take four to six weeks, while active suicidal ideation with intent constitutes a psychiatric emergency that requires immediate intervention. The company said its studies are the first global trials in this patient population, who are typically excluded from antidepressant treatment studies.

The U.S. Food and Drug Administration in March approved Spravato for patients with treatment-resistant depression, meaning they have been unable to find relief from at least two treatments.

The nasal spray is a close chemical relation to ketamine, an anesthetic that is often abused as a party drug but has been shown to have a fast-acting impact on depression symptoms.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 09, 2019 10:31 ET (14:31 GMT)

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