RISPERDAL* Consta is the first
atypical antipsychotic drug of a new generation.
The long-acting parenteral form of this product
was launched by Janssen-Cilag GmbH in Germany
on August 15, 2002, followed shortly afterwards
by the United Kingdom. In a number of other countries,
RISPERDAL Consta is in late-stage regulatory review
by the national regulatory agency.
RISPERDAL Consta is prescribed for the management
of schizophrenia – a brain disorder affecting
1-2 percent of the world's population. It is administered
once every two weeks, rather than daily as with
the oral form. Until now, long-acting injectable
formulations of antipsychotics have been available
only for older, conventional drugs. However, these
conventional antipsychotics can cause serious
motor disorders and are considered by most experts
to be less effective in treating 'negative' symptoms
(such as social withdrawal and apathy) and in
alleviating 'positive' symptoms (including hallucinations
and delusions).
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 in tablet
form by Janssen-Cilag since 1994 and is the most
widely prescribed atypical antipsychotic in the
world.
Using proprietary Medisorb® technology developed
by U.S.-based Alkermes, Inc., the new formulation
encapsulates risperidone in microspheres made
of a biodegradable polymer. These microspheres
are suspended in a water-based solution and injected
into the muscle. Laboratory and clinical research
have shown that the microspheres gradually degrade
at a set rate to provide therapeutic concentrations
of the drug in the bloodstream. The polymer from
which the microspheres are made breaks down into
two naturally occurring compounds, which are then
eliminated by the body. RISPERDAL Consta is manufactured
by Alkermes. More information on this company
and its technologies can be found on www.alkermes.com
* Names in capital letters are trademarks
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