The U.S. Food and Drug Administration (FDA) has approved the antipsychotic Caplyta (lumateperone) for the treatment of bipolar depression in adults, either as a monotherapy or an adjunct therapy with lithium or valproate. Caplyta, marketed by Intra-Cellular Therapies Inc., is already approved for the treatment of schizophrenia in adults.
The FDA approval was based on positive findings from two six-week, phase 3 trials. The first trial evaluated the effects of 42 mg/day lumateperone monotherapy versus placebo in 381 adults aged 18 to 75 with bipolar I or II depression. The second trial evaluated 28 mg/day or 42/mg day lumateperone versus placebo in 529 adults with bipolar I or II depression who were also taking lithium or valproate.
In both studies, participants taking 42 mg/day lumateperone showed statistically stronger improvements in their depression symptoms after six weeks compared with those taking placebo. In the monotherapy study, which was published in AJP in Advance in September, Montgomery-Åsberg Depression Rating scale (MADRS) scores dropped by an average of 16.7 points after six weeks in the lumateperone group compared with 12.1 points in the placebo group. In the adjunct therapy study, MADRS scores dropped by an average of 16.9 points after six weeks in the lumateperone group compared with 14.5 points in the placebo group. The data suggested that lumateperone was effective at treating both bipolar I and bipolar II depression.
Lumateperone also demonstrated a favorable safety profile in both studies. The most common side effects were sleepiness, dizziness, nausea, and dry mouth. Lumateperone was not associated with any significant issues of weight gain, cardiometabolic problems, or extrapyramidal symptoms.
“The efficacy and favorable safety and tolerability profile make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” said Roger McIntyre, M.D., head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Toronto, in a media release. McIntyre has received consulting fees and research support from Intra-Cellular Therapies.
For related information, see the American Journal of Psychiatry articles “Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial” and “Slowly Working Toward More Treatments for Depression in Bipolar II Disorder.”
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