Long-acting risperidone approved by FDA.

 The AP (5/18) reported that “Alkermes Inc. said Monday its partner Johnson & Johnson received Food and Drug Administration approval for the long-acting version of Risperdal [risperidone] as a treatment for bipolar disorder.” The medication, known as Risperdal Consta [risperidone], is “a long-acting injectable drug, [which] is already approved as a schizophrenia treatment. Meanwhile, the pill version of Risperdal is approved for short-term treatment of bipolar disorder, as a schizophrenia treatment, and as an autism drug.”

According to Reuters (5/18, Nathan), Johnson & Johnson’s Janssen Pharmaceuticals unit received a letter from the FDA in February requesting additional data on Risperdal Consta. Monday’s “approval is based on two studies, the first of which demonstrated that the drug used alone worked better than a placebo at delaying relapses in the disease characterized by extreme mood shifts,” Dow Jones Newswires (5/19, Stynes) reports. “The second showed the drug significantly delayed relapses among patients who already were taking lithium or valproate.”

HealthDay (5/18, Roberts) noted, “As with similar antipsychotic drugs, the packaging for Risperdal Consta includes a warning that the drug is not approved for elderly people with dementia-related psychosis, and could increase their risk of death.”

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