J&J's Caplyta meets main goal of bipolar mania study
Johnson & Johnson's experimental drug Caplyta met the main goal of a late-stage study for bipolar mania, showing a significant reduction in symptoms compared to placebo. The study also met a key secondary goal, with about 46% of treated patients achieving a clinical response compared to 21% on placebo.
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. 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.
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. com;)