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| What is the worst source of info on drugs? - Big Pharma press releases on their own product. |
.SPRAVATO® (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression
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| Special K (ketamine) is called a psychedelic. |
[Matthew "Chandler" Perry would love it, wouldn't he?] Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours [1].
SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis [2].
Monotherapy data adds to well-established clinical efficacy and real-world safety profile
TITUSVILLE, New Jersey, Jan. 21, 2025 – Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
MDD is one of the most common psychiatric disorders, with an estimated
21 million adults in the U.S. living with the disease. About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected. MDD has a high economic burden, with nearly half of it attributable to treatment-resistant depression (TRD) [3,4,5].
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