October 10, 2008

Alkermes Announces FDA Approval of New Injection Site for Risperdal Consta

Alkermes, a biotechnology company, has announced that patients with schizophrenia now have a new administration option for Risperdal Consta. The FDA has approved a new injection site, the deltoid muscle in the arm, for Risperdal Consta for the treatment of patients with schizophrenia. It was previously approved as a gluteal injection only.

The application was based on a study showing that the deltoid and gluteal injections of Risperdal Consta were bioequivalent routes of administration and thus interchangeable. An additional study was conducted that showed the safety and tolerability of Risperdal Consta injected into the deltoid muscle were similar to the gluteal injections.

The new Risperdal Consta dose packs will now include two separate (non-interchangeable) needles for injection and will be available to US physicians by the end of 2008. The needle for deltoid injection is a smaller gauge and is shorter in length than the gluteal needle. Both are administered every two weeks. Not all patients will be appropriate for the deltoid injection site.

Risperdal Consta is marketed in the US by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, and manufactured by Alkermes.

John Kane, chairman of psychiatry at The Zucker Hillside Hospital, said: "Risperdal Consta serves an important role in the treatment of schizophrenia by providing consistent levels of medication over a two-week period. The ability to inject Risperdal Consta in the upper arm may be easier for some patients and physicians and also gives patients a choice of where to receive their long-acting therapy."