Wednesday, February 11, 2009

FDA: Alkermes needs more bipolar drug data

By Marc Songini

The U.S. Food and Drug Administration is looking for more information about Cambridge-based biotech company Alkermes Inc.’s bipolar disorder treatment drug Risperdal Consta before it considers granting permission to expand its usage.

Risperdal Consta is manufactured by Alkermes but currently is marketed in the U.S. by Ortho-McNeil-Janssen Pharmaceuticals Inc. It was initially approved to treat schizophrenia in the United States in 2003 and is registered in more than 80 countries. Alkermes’ partner Johnson & Johnson Pharmaceutical Research & Development LLC had submitted a supplemental New Drug Application (NDA) for Risperdal Consta in April 2008. This supplemental NDA asked permission to use Risperdal Consta for certain applications in bipolar patients that relapsed frequently.

Alkermes (Nasdaq: ALKS) this week announced the FDA had asked for additional information about the drug. The FDA’s response outlined questions requiring an answer prior to granting approval for this new indication; However, the agency didn’t request additional studies. J&JPRD is evaluating the FDA’s response letter and will work to resolve any outstanding questions, Alkermes said.

A bipolar disorder causes unusual shifts in mood, energy and functional ability. It is characterized by debilitating mood swings from high to low, or from mania to depression, respectively. It affects 5.7 million, or 2.6 percent, of American adults each year.

Alkermes’ pipeline includes extended-release injectable, pulmonary and oral products to treat prevalent chronic diseases, such as central nervous system disorders, addiction and diabetes. Alkermes maintains research facilities in Massachusetts and a commercial manufacturing plant in Ohio.