Janssen says FDA approves new lower Risperdal dose

The new dose will treat specific patient populations, including those with renal and hepatic impairment.

Risperdal Consta is manufactured by Alkermes and marketed in the US by Janssen. Janssen said the new dose of Risperdal Consta would provide physicians with more options to individualize treatment approaches and adjust therapies when clinical factors warrant dose changes.

“This smaller dose will be relevant for patients who may be at risk for drug-drug interactions which could increase the plasma concentrations of Risperdal Consta, or in patients who have a history of low tolerability to the usual starting doses of psychotropic medications,” said Henry Nasrallah, director of the Schizophrenia Research Program at the University of Cincinnati.

The new dose of Risperdal Consta, which is expected to be available by May 1, is the lowest formulation of the long-acting injection. Risperdal Consta is also available in 25mg, 37.5mg and 50mg dose units. The FDA approval of the 12.5mg dose was based on pharmacokinetic data in schizophrenia patients that demonstrated an expected profile for the lower dosage strength. The efficacy of the 12.5mg dose has not been investigated in clinical trials.