TITUSVILLE, N.J., Oct. 9 /PRNewswire-FirstCall/ -- Patients with schizophrenia now have a new administration option for RISPERDAL(R) CONSTA(R) ([risperidone] Long-Acting Injection). The U.S. Food and Drug Administration (FDA) has approved a new injection site, the deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment of patients with schizophrenia. RISPERDAL CONSTA was previously approved as a gluteal injection only.

'For many patients, this injection site may be a good option, as it will provide them with a choice of where to receive their long-acting therapy,' said Dr. Mohammed Bari, of Synergy Research Center in San Diego and one of the investigators in the trial.* 'The fact that they will just have to roll up their sleeves and get the shot in their arm is going to be a big plus for many patients with schizophrenia.'

The application was based on a study showing that the deltoid and gluteal injections of RISPERDAL CONSTA were bioequivalent(a) 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. Both studies were presented earlier this year at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C., 2008.(1, 2)

The new RISPERDAL CONSTA dose packs will now include two separate (non-interchangeable) needles for injection and will be available to U.S. 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. As with all medications, it's important that patients discuss their treatment options with their healthcare professional.

RISPERDAL CONSTA is marketed in the U.S. by Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL CONSTA was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes' proprietary Medisorb(R) drug-delivery technology, the RISPERDAL CONSTA formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com.