J&J's Spravato Meets Primary Phase 3 Endpoints in Imminent Suicide Risk
10 September 2019 - 12:46AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 09, 2019 10:31 ET (14:31 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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