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Jump to Key Points Sept 21 (Reuters) - Johnson & Johnson said on Monday its experimental use of Caplyta for bipolar mania met the main goal of a late-stage study, bringing the drug a step closer to expanding beyond its currently approved uses.
J&J gained Caplyta through its $14.6 billion acquisition of Intra-Cellular Therapies last year to bolster its neuroscience business.
• Caplyta significantly reduced symptoms of bipolar mania compared with placebo in the late-stage trial, meeting the study's main goal, J&J said.
• Symptoms of mania can include grandiosity, decreased need for sleep, racing thoughts, distractibility, and risk-taking behavior.
- Caplyta met primary endpoint in bipolar I mania trial.
- Once-daily 42 mg improved mania symptoms vs placebo.
- Benefit seen by day 3; sustained through 3-week study.
- Secondary endpoint: overall illness severity also improved.
- Response rate: 46% Caplyta vs 21% placebo.
• Patients showed improvement as early as three days after starting treatment with the drug, with benefits maintained through the study's three-week duration, according to the company.
• The study also met a key secondary goal measuring overall severity of illness, J&J said.
• About 46% of patients treated with Caplyta achieved a clinical response, compared with about 21% of patients who received placebo, the company said.
• The trial evaluated a once-daily 42-milligram dose of Caplyta in adults experiencing manic episodes associated with bipolar I disorder.
• J&J's Caplyta is already approved in the United States for depressive episodes associated with bipolar I and bipolar II disorder and schizophrenia.
• Bipolar disorder affects an estimated 37 million people worldwide. Mania, a defining feature of bipolar I disorder, is marked by unusually elevated or irritable mood and increased energy or activity levels that often occur alongside depressive episodes, according to J&J.
(Reporting by Sahil Pandey in Bengaluru; Editing by Shailesh Kuber)
