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September 23, 2008 • Volume 5 / Number 19 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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FDA Update

FDA Approves Anti-nausea Patch, Expands Indication of HPV Vaccine

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A skin patch developed to prevent the nausea and vomiting often induced by chemotherapy was approved by the Food and Drug Administration (FDA) earlier this month. The patch, called Sancuso, is expected to be available to patients later this year.

Sancuso delivers granisetron, an established inhibitor of nausea and vomiting that is currently available in oral and intravenous forms. The patch was designed to release granisetron slowly into the patient's bloodstream for up to 5 consecutive days.

According to ProStrakan, the Scottish company that developed the patch, Sancuso was generally well-tolerated by patients in clinical trials. The most common drug-related adverse reaction was constipation. Skin reactions at the application site were reported but were mild and did not lead to discontinuation of use.

Earlier this month, the FDA also expanded its approval of the HPV vaccine Gardasil for the prevention of vaginal and vulvar cancers.

Manufactured by Merck & Co., Gardasil was first approved for women and girls aged 9 to 26 by the FDA in 2006 to prevent infection by HPV types 16, 18, 6, and 11. These four HPV types together cause 70 percent of cervical cancers, 90 percent of genital warts, and an unspecified percentage of vulvar and vaginal cancers.

After following 15,000 participants from the original studies for 2 additional years, researchers found that Gardasil was highly effective in preventing the types of precancerous vulvar and vaginal lesions caused by HPV. Among women who had not received the vaccine, 9 developed precancerous vaginal lesions and 10 developed precancerous vulvar lesions, whereas no such cases were found in the Gardasil group.

This is "strong evidence," said Dr. Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research. "While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV."