Johnson & Johnson reports second positive Phase 3 trial of CAPLYTA for bipolar mania
Johnson & Johnson announced that Study 452, its second pivotal Phase 3 trial of CAPLYTA (lumateperone) in adults with bipolar I manic episodes, met its primary and key secondary endpoints. The drug produced a 3.7‑point greater reduction in Young Mania Rating Scale scores versus placebo at Week 3, with significant improvement as early as Day 3. Nearly 44% of patients achieved a ≥50% YMRS improvement compared with 24% on placebo. The company said the results will support a planned U.S. FDA submission for this new indication.
Why it matters
The company expects the data to underpin an FDA filing that could add a bipolar‑mania indication to CAPLYTA’s label, potentially expanding its market and revenue stream. The news lifted JNJ shares, which closed at $282.11, up 2.13% after the announcement.
Key facts
- 1Study 452 evaluated once‑daily CAPLYTA 42 mg versus placebo over three weeks in adults with bipolar I manic episodes. prnewswire.com
- 2CAPLYTA showed a statistically significant 3.7‑point greater reduction in YMRS total score versus placebo at Week 3. prnewswire.com
- 343.9% of CAPLYTA‑treated patients achieved at least a 50% YMRS improvement versus 23.7% on placebo. prnewswire.com
- 4The trial met the key secondary endpoint of greater improvement on the Clinical Global Impression–Severity score (LSMD −0.41; P=.0003). prnewswire.com
- 5CAPLYTA was well‑tolerated; the most common treatment‑related adverse events (≥5% and at least twice placebo) were dizziness, dry mouth and somnolence/sedation. prnewswire.com
- 6Johnson & Johnson plans to submit the data to the U.S. FDA to seek approval for bipolar‑mania treatment. rttnews.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.