TITUSVILLE, N.J. - Johnson & Johnson (NYSE:JNJ) has received approval from the U.S. Food and Drug Administration (FDA) for SPRAVATO® (esketamine) nasal spray as a standalone treatment for adults with major depressive disorder (MDD) who haven't adequately responded to at least two different oral antidepressants. This marks the first time a treatment has been approved as a monotherapy for MDD.
The approval, announced today, follows a Priority Review by the FDA and is based on a study demonstrating the drug's rapid and significant improvement in depressive symptoms compared to placebo. The study showed that patients treated with SPRAVATO® alone experienced relief from depressive symptoms as early as 24 hours after administration, with continued improvement at 28 days. With last twelve months revenue of $87.7 billion and a strong cash flow position, J&J demonstrates the financial capability to support major product launches like SPRAVATO®.
SPRAVATO® acts on the brain's glutamate pathway, a new approach in the treatment of depression. The exact mechanism by which esketamine exerts its antidepressant effect is not fully understood. However, the treatment has been administered to over 140,000 patients globally and is backed by a decade of research.
The drug's safety profile as a monotherapy is consistent with its known effects when used in conjunction with oral antidepressants, with no new safety concerns identified. Due to potential risks of sedation, dissociation, respiratory depression, abuse, and misuse, SPRAVATO® will only be available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program.
MDD affects an estimated 21 million adults in the U.S., and about one-third of these patients do not respond to oral antidepressants alone. The approval of SPRAVATO® as a monotherapy provides a new option for healthcare providers to personalize treatment plans and offer rapid symptom improvement without the need for daily oral antidepressants. For deeper insights into J&J's market position and growth potential, InvestingPro subscribers can access comprehensive analysis, including 8 additional ProTips and detailed financial metrics in the Pro Research Report, helping investors make informed decisions about this healthcare leader's future prospects.
This information is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has initiated the FDA approval process for TAR-200, a novel treatment for bladder cancer. The drug has shown promising results in the Phase 2b SunRISe-1 study, which reported an 83.5 percent complete response rate among participants. Meanwhile, the company's credit rating is under review by S&P Global Ratings due to its acquisition of Intra-Cellular Therapies (NASDAQ:ITCI) Inc., which is expected to temporarily increase the company's leverage.
Furthermore, Morgan Stanley (NYSE:MS) has reaffirmed its Equalweight rating for Johnson & Johnson, following the recent acquisition, citing the strategic fit for the company's portfolio. On a different note, the FDA has granted Fast Track designation to Johnson & Johnson for two investigational Alzheimer's disease therapies, potentially leading to earlier patient access. However, concerns have arisen regarding the company's cardiac ablation device, Varipulse, leading to a temporary halt in its use while the company investigates the cause behind four neurovascular events.
These are recent developments for Johnson & Johnson, reflecting its ongoing efforts in pharmaceutical innovation, strategic acquisitions, and patient safety.
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