New treatment garners FDA approval for bipolar I disorder

 Johnson & Johnson's Risperdal Consta (risperidone) has been granted FDA approval for the treatment of bipolar I disorder. As an adjunctive therapy to lithium or valproate, Risperdal Contra was approved as a monotherapy, bi-weekly injectable drug in the maintenance treatment of the condition.

Authorization by the FDA was based on two randomised studies for the long-term treatment of bipolar I disorder. The first study showed that the drug alone delayed relapse time significantly of any extreme mood swing occurence. Data from the second study showed that the time of relapse was markedly delayed in patients taking valproate or lithium combined with the Johnson & Johnson drug, juxtaposed with those receiving current treatments with a placebo. 

“Long-acting therapies are moving to the forefront of treatment for mental illness, and the approval of Risperdal Constra for bipolar disorder is exciting because it offers physicians assurance that the medication is being taken as prescribed,” said Caleb Adler, M.D., principal investigator and associate professor of Clinical Psychiatry at the University of Cincinnati. He continued, “Further, the bi-weekly administration schedule encourages regular contact between patients and their treatment team.”

Risperdal Consta is already approved in the US to treat schizophrenia.

Article attributed to Business Wire and Firstwordplus.com