These studies show that ALOXI was effective in the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. In study 3, efficacy was greater when prophylactic corticosteroids were administered concomitantly. Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase.

Table 3: Prevention of Delayed Nausea and Vomiting (24-120 hours): Complete Response Rates

Chemotherapy	Study	Treatment Group	N a	% with Complete Response	p-value b	97.5% Confidence Interval ALOXI minus Comparator c
Moderately Emetogenic	1	ALOXI 0.25 mg	189	74	<0.001
		Ondansetron 32 mg IV	185	55
	2	ALOXI 0.25 mg	189	54	0.004
		Dolasetron 100 mg IV	191	39
a Intent-to-treat cohort b 2-sided Fisher's exact test. Significance level at α=0.025. c These studies were designed to show non-inferiority. A lower bound greater than –15% demonstrates non-inferiority between ALOXI and comparator.

These studies show that ALOXI was effective in the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.

Table 4: Prevention of Overall Nausea and Vomiting (0-120 hours): Complete Response Rates

Chemotherapy	Study	Treatment Group	N a	% with Complete Response	p-value b	97.5% Confidence Interval ALOXI minus Comparator c
Moderately Emetogenic	1	ALOXI 0.25 mg	189	69	<0.001
		Ondansetron32 mg IV	185	50
	2	ALOXI 0.25 mg	189	46	0.021
		Dolasetron 100 mg IV	191	34
a Intent-to-treat cohort b 2-sided Fisher's exact test. Significance level at α=0.025. c These studies were designed to show non-inferiority. A lower bound greater than –15% demonstrates non-inferiority between ALOXI and comparator.

These studies show that ALOXI was effective in the prevention of nausea and vomiting throughout the 120 hours (5 days) following initial and repeat courses of moderately emetogenic cancer chemotherapy.

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