FDA Gives Thumbs Down to New Glaxo Nausea Drug

The Food and Drug Administration is so far refusing to approve a new GlaxoSmithKline Plc drug designed for patients who experience nausea after undergoing cancer treatments or during recovery from surgery.

The FDA has not flat-out rejected the drug, Rezonic, but Glaxo has been notified that more specific information about the drug will be required before the FDA will approve it, officials said. Until the company reviews the FDA letter and provides the required additional information, the approval process is at a stand-still.

“That essentially stops the review clock and allows a company to amend the application, then re-start the review process,” a Glaxo spokeswoman said, according to a Reuters report.

The FDA issues complete response letters to drug makers when staff members have completed their review of clinical trial data and other information provided by the companies. It is not unusual for staff members to request additional data before proceeding with the drug-approval process.

Rezonic, which is also available in generic form as casopitant, is intended to treat patients who experience nausea following cancer treatments or surgery. Glaxo filed an approval application for Rezonic with the FDA in May 2008.

Glaxo reportedly plans to sell Rezonic in combination with another of the company’s nausea drugs, called Zofran, and a third drug, called dexamethasone.

Rezonic has been the source of controversy before. In May 2009, the FDA cancelled a meeting of a public advisory board that had been scheduled to consider recommending approval of the drug.

If approved, Rezonic would join an increasingly crowded market of drugs to treat nausea brought on by chemotherapy and surgery. Drugs already approved for the treatments include Emend, Aloxi, and Marinol.

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