FDA approval for new Risperdal injection site

The USA's Janssen, a division of Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals, has received Food and Drug Administration approval of a new injection site, the deltoid muscle, for Risperdal Consta (risperidone injection) for the treatment of patients with schizophrenia.

The approval was based on a study showing that the deltoid and gluteal injections of Risperdal were bioequivalent routes of administration. An additional trial was conducted that showed the safety and tolerability of the injection sites were similar. Both studies were presented earlier this year at the annual meeting of the American Psychiatric Association in Washington DC.

The firm says new dose packs will include two separate, non-interchangeable needles by the end of 2008. The needle for deltoid injection is a smaller gauge and is shorter in length than the gluteal one, but not all patients will be suited to the new injection site.