Regulators in the US have expanded the use of Bristol-Myers Squibb/Otsuka Pharmaceuticals' antipsychotic Abilify to include the maintenance treatment of patients with bipolar I disorder.
The US Food and Drug Administration has OK'd the drug as an adjunct to the mood stabilisers lithium or valproate for maintenance of patients with the condition, which follows its approval as an acute therapy in this setting in 2008.
The green light was based on findings from a 52-week maintenance trial which showed that a combination of Abilify (aripiprazole) and lithium or valproate in patients was superior to adjunctive placebo in extending the time to relapse of any mood event (defined as hospitalisation for a manic, mixed or depressive episode, study discontinuation due to lack of efficacy, or worsening disease).
Discovered by Otsuka and jointly developed and commercialised by Otsuka and B-MS, Abilify is the first and only available dopamine partial agonist on the market, according to the firms.
The drug is also approved as a monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and as a maintenance treatment, as well as an adjunctive therapy to antidepressants in adults with Major Depressive Disorder, treatment for schizophrenia, and management of irritability associated with autistic disorder in paediatric patients.
Abilify pulled in sales of $608 million in the fourth quarter of last year, remaining relatively flat with the year-earlier period, but its new indication could breathe a little new life into its performance.