On Monday, Intra-Cellular Therapies announced that the FDA has approved CAPLYTA to treat the deep depressive episodes of patients with bipolar I or II.
CAPLYTA got second FDA approval for bipolar depression. (Sarah Silbiger/Getty Images)
Intra-Cellular Therapies is delivering hope of a brighter 2022 for adults with bipolar I or II disorder. On Monday, the company announced that the FDA has approved CAPLYTA to treat the deep depressive episodes of patients with the mental health condition.
“CAPLYTA is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate,” said Intra-Cellular CEO Dr. Sharon Mates. “We are positioned to launch immediately and are excited to offer CAPLYTA to the millions of patients living with bipolar depression.”
Significance of CAPLYTA Approval
Bipolar disorder affects around 11 million U.S. adults. The mental condition is characterized by the highest highs and lowest lows - periods of intense mania interspersed with lengthy times of deep depression. While a high number of products exist to manage the acute mania symptoms, there is a vast clinical need for treating the depression that follows.
These depressive episodes are the most common and debilitating symptom of the disorder. The depression lasts longer, rears its ugly head more frequently and often leads to self-harm. In fact, between 25 and 60% of individuals with bipolar disorder will attempt to commit suicide at least once, while 4 to 19% will, sadly, succeed.
With the lack of antidepressant monotherapies for bipolar depression on the market, antidepressants are typically prescribed off-label, in combination with an antimanic agent. Long-term use of these products, however, is typically limited due to side effects.
The approval of this new treatment option for bipolar patients is based on two Phase III, placebo-controlled trials in adults experiencing a depressive episode. Over the six weeks of the trial, those on CAPLYTA showed a “statistically significant improvement” over the placebo on the Montgomery-Asberg Depression Rating Scale and clinical global impression of the disorder. Having been evaluated during acute depressive episodes, further study potential remains for the therapy as a long-term preventative.
CAPLYTA was first approved two years ago, nearly to the day, to treat schizophrenia in adults. While Intra-Cellular doesn’t even quite understand the mechanism of action that allows it to treat these conditions, the drug has proved its worth against a placebo for both indications. The most common side effects are drowsiness, nausea, dizziness and dry mouth.
The drug is being studied for the treatment of major depressive disorder along with other neuropsychiatric and neurological disorders.
Sunovion Pharmaceuticals also has a drug in Phase III development for the depressive episodes associated with bipolar I disorder. It’s one of the four neuropsych drugs included in a recently forged $1 billion deal between Otsuka Pharmaceutical and Sunovion’s parent company, Sumitomo Dainippon Pharma Co., Ltd.
