JnJ eyes expanded USFDA approval for Caplyta for prevention of relapse in schizophrenia

“For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients’ goals, and increase the risk of hospitalization with each episode,” said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York. “CAPLYTA substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families.”

The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.

Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving care. When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved ones. Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of hospitalization. On average, an adult with schizophrenia experiences nine relapses in less than six years.

“Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression. We’re committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders.”

While its exact mechanism of action is unknown, CAPLYTA is characterized by high serotonin 5-HT_2A receptor occupancy and lower amounts of dopamine D₂ receptor occupancy at therapeutic doses. In short-term clinical studies, CAPLYTA was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. CAPLYTA can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose.

CAPLYTA is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An sNDA for CAPLYTA as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA has the potential to become a new standard of care to treat some of today’s most prevalent and debilitating mental health disorders.