MCA approves Risperdal Consta for UK market launch

The UK Medicines Control Agency (MCA) has approved Janssen-Cilag's Risperdal Consta (risperidone), a long-acting injection developed for a newer generation, atypical antipsychotic. Risperdal Consta was also approved recently in Germany, and a launch in both countries was expected during August. The product is in late-stage regulatory review in a number of other countries.

Risperdal Consta is administered every two weeks, rather than daily, for the management of schizophrenia. Patients with a chronic illness, and particularly a psychotic condition, may find it difficult to remember to take medication daily, and long-acting injections can help assure consistent, known delivery of medication. However, until now, these have been available only for older, conventional antipsychotics.

Risperdal Consta was developed by Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) to combine the advantages of long-acting delivery with the established benefits of oral risperidone. Risperdal has been marketed by Janssen-Cilag as tablets and oral solution for more than seven years.

Using proprietary Medisorb technology developed by US-based Alkermes, the new formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. 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.