Johnson & Johnson Submits Schizophrenia Drug CAPLYTA sNDA to FDA Based on Positive Relapse Prevention Data

Johnson & Johnson (NYSE:JNJ) is one of the most undervalued NYSE stocks to buy now. On July 8, Johnson & Johnson announced the submission of a supplemental New Drug Application/sNDA to the US FDA for its schizophrenia drug called CAPLYTA (lumateperone). The submission is based on long-term Phase 3 clinical data demonstrating CAPLYTA’s safety and efficacy in preventing relapse in adults with schizophrenia.

The Phase 3, double-blind, multicenter, placebo-controlled, and randomized withdrawal trial showed compelling results. The primary endpoint indicated that the time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA compared to those on placebo (p=0.0002).

A smiling baby with an array of baby care products in the foreground.

Schizophrenia is a complex and chronic brain disorder affecting an estimated 2.8 million adults in the US, yet ~40% of those affected do not receive adequate care. Relapses are characterized by a recurrence of symptoms and can disrupt lives, undo treatment progress, and increase the risk of hospitalization. On average, an adult with schizophrenia experiences 9 relapses in less than 6 years.

Johnson & Johnson (NYSE:JNJ) engages in the research and development, manufacture, and sale of various products in the healthcare field worldwide.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.