Roche announced the U.S. Food and Drug Administration (FDA) granted approval of its antiemetic, Kytril Injection (granisetron hydrochloride) for both the prevention and treatment of post-operative nausea and vomiting (PONV). When used for prevention, Kytril is given just before or during surgery to prevent PONV from occurring. In the case of treatment, Kytril is given to a patient who experiences PONV after surgery is completed. This approval was based on randomized, double blind clinical trials.

Kytril Injection was evaluated in two randomized, double blind, placebo-controlled studies in patients who underwent gynecological surgery or cholecystectomy and received general anesthesia. In one study, patients between the ages of 18 and 88 received a single intravenous dose of Kytril Injection (0.1, 1 or 3 mg) or placebo five minutes before induction of anesthesia. In another study, patients between the ages of 21 and 64 received a single intravenous dose of Kytril Injection (1 or 3 mg) or placebo immediately before the reversal of anesthesia. In both studies, Kytril Injection (1 mg) was significantly more effective (p<0.001) than placebo in preventing postoperative nausea and vomiting.

Kytril Injection was evaluated in two randomized, double blind, placebo-controlled studies of adult surgical patients who received general anesthesia and no prophylactic antiemetic treatment, and who experienced nausea and vomiting within four hours after surgery. In one study, patients between the ages of 18 and 86 received a single intravenous dose of Kytril Injection (0.1mg, 1mg or 3 mg) or placebo after experiencing postoperative vomiting or severe nausea. This study showed that Kytril Injection given at 0.1mg, 1mg and 3 mg doses were significantly more effective (p?0.001) than placebo in preventing further episodes of nausea and vomiting. Furthermore, this study demonstrated efficacy at both time intervals of 0 to 6 hours and 0 to 24 hours for the treatment of PONV.

The recommended dose of Kytril for prevention and treatment of post operative nausea and vomiting is 1 mg. The most common adverse events reported in the postoperative nausea and vomiting trials included pain, headache and fever.