NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ), Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with treatment-resistant depression, a psychiatric disorder.
The approval is supported by the company's study, which met its primary endpoint in four weeks, and showed a rapid and superior improvement in depressive symptoms, compared to placebo as early as 24 hours.
Moreover, the safety profile of Spravato, as a standalone treatment, was consistent with the existing body of clinical and real-world data.
In the pre-market hours, JNJ is trading at $147.28, up 0.17 percent on the New York Stock Exchange.
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