FDA Issues Complete Response Letter for RISPERDAL(R) CONSTA(R) for the Adjunctive Maintenance Treatment of Bipola...( TITUSVILLE N.J. Feb. 10 /- Johnson &a...)

TITUSVILLE, N.J., Feb. 10 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional information regarding the company's supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection. The sNDA, submitted in April 2008, sought approval for RISPERDAL(R) CONSTA(R) for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.

The Agency's complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies.

J&JPRD is currently evaluating the FDA's complete response letter and will work with the Agency to resolve any outstanding questions.

Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression), and affects 5.7 million, or 2.6 percent, of the American adult population in any given year.(1)

RISPERDAL(R) CONSTA(R) is marketed in the U.S. by Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL(R) CONSTA(R) 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(R) CONSTA(R) 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 blo
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