Medical Technology

FDA provides new indications for Lumateperone in Bipolar Depression

The US Food and Drug Administration (FDA) has widened the approval granted to Lumateperone (Caplyta) to include treatment for adults suffering from depression-related episodes that are related to bipolar I and II disorder. It can be used in monotherapy or adjunctive therapy with Lithium or Valproate.

This makes lumateperone the only FDA-approved medication for this indication.

“Caplyta’s efficacy and favorable safety profile make it a crucial treatment option to the millions of patients suffering from bipolar I/I depression,” Roger McIntyre MD, professor of psychiatry, University of Toronto, Canada and the head of the Mood Disorders Psychopharmacology Unit stated in a press release issued by the company.

As as reported by Medscape Medical News,lumateperone was first approved by the FDA in 2019 for the treatment of adults suffering from schizophrenia.

“Positioned for the launch immediately”

Two studies in phase 3 have demonstrated that lumateperone, either alone or in combination with lithium or valproate improved the depressive symptoms of patients suffering from major depression episodes related to bipolar I or II disorders.

The studies found that 42 mg of once-daily treatment was associated with significantly more Montgomery-Asberg Depression Rating Scale score (MADRS) improvement than placebo. This is previously reported in Medscape Medical News.

Lumateperone also showed statistically significant improvements in the secondary endpoint relating to the clinical impressions of bipolar disorder.

Diazziness, vomiting dry mouth, and dizziness were the most commonly reported adverse reactions that were associated with the medication. There were no significant changes in weight and vital signs and in the results of endocrine or metabolic tests. Extrapyramidal symptoms-related events were uncommon and similar to those seen in placebo.

Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, stated in the same press release “The company is positioned to launch immediately and is thrilled to introduce Caplyta for the millions of patients suffering from bipolar disorder..”

Full prescription information is accessible online.

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