A drug that treats major depressive episodes associated with bipolar depression improved symptoms in a statistically significant way in a human clinical study, according to its developer, Sunovion Pharmaceuticals of Marlborough.
In a six-week, randomized, double-blind, placebo-controlled study, 347 children between the ages of 10 and 17 with bipolar depression were given a flexible dose of the drug, Latuda, once a day. Children who were given Latuda showed clinically meaningful improvement in bipolar depression symptoms when compared to placebo.
The drug was generally well-tolerated, with nausea, drowsiness, weight gain, vomiting, dizziness and insomnia as the most common side effects.
Latuda is currently indicated in the U.S. for the treatment of adults with bipolar depression. The new data have been submitted to the U.S. Food and Drug Administration to support a supplemental new drug application.
