Intra-Cellular Therapies (NSDQ:ITCI) has announced that Caplyta (lumateperone) has become the only FDA-approved monotherapy for depressive episodes linked to bipolar I or II disorder (bipolar depression). The approval also covers its use as adjunctive therapy with lithium or valproate.
Lumateperone was initially FDA approved in 2019 as an atypical antipsychotic for treating schizophrenia in adults.
Traditional pharmacological treatments of bipolar disorder include antipsychotics, mood stabilizers, antidepressants and anti-anxiety medications.
Some 11 million U.S. adults have bipolar depression.
Bristol Myers Squibb originally discovered lumateperone and licensed it to Intra-cellular Therapies in 2005.
To win the expanded indication for Caplyta, Intra-Cellular Therapies submitted data from two Phase 3 placebo-controlled bipolar depression trials involving volunteers with bipolar I and II disorder.
The difference between bipolar I and II lies in the severity of manic episodes, with the former being more severe than the latter.
Filed Under: clinical trials, Drug Discovery, Neurological Disease, Psychiatric/psychotropic drugs