Twenty-two percent (22%) of patients treated with KYTRIL Tablets did not experience vomiting or receive rescue antiemetics over the entire 4-day dosing period, compared to 0% of patients in the historical negative control group (P < 0.01).

In addition, patients who received KYTRIL Tablets also experienced significantly fewer emetic episodes during the first day of radiation and over the 4-day treatment period, compared to patients in the historical negative control group. The median time to the first emetic episode was 36 hours for patients who received KYTRIL Tablets.

Fractionated Abdominal Radiation

The efficacy of KYTRIL Tablets, 2 mg daily, was evaluated in a double-blind, placebo- controlled randomized trial of 260 patients. KYTRIL Tablets were given 1 hour before radiation, composed of up to 20 daily fractions of 180 to 300 cGy each. The exceptions were patients with seminoma or those receiving whole abdomen irradiation who initially received 150 cGy per fraction. Radiation was administered to the upper abdomen with a field size of at least 100 cm².

The proportion of patients without emesis and those without nausea for KYTRIL Tablets, compared to placebo, was statistically significant (P < 0.0001) at 24 hours after radiation, irrespective of the radiation dose. KYTRIL was superior to placebo in patients receiving up to 10 daily fractions of radiation, but was not superior to placebo in patients receiving 20 fractions.

Patients treated with KYTRIL Tablets (n=134) had a significantly longer time to the first episode of vomiting (35 days vs. 9 days, P < 0.001) relative to those patients who received placebo (n=126), and a significantly longer time to the first episode of nausea (11 days vs. 1 day, P < 0.001). KYTRIL provided significantly greater protection from nausea and vomiting than placebo.

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