A.P. Pharma says its experimental therapy to prevent nausea and vomiting induced by chemotherapy hit the primary endpoint in three of four assessments outlined in a Phase III comparison trial with standard therapy. The study set out to compare the efficacy of two different doses of APF530 with Aloxi in four assessments.
Reuters highlighted the failure of the drug in one of four assessments in its report, but A.P. Pharma's release stressed the positive and the company says it's on track to file for an approval.
According to the biotech, "the results met the primary endpoint of "non-inferiority" (comparability) for three assessments, including moderately emetogenic (acute and delayed onset) and highly emetogenic (acute onset), but did not achieve the primary endpoint of superiority for the highly emetogenic delayed onset assessment."
Researchers also said that the 10 mg dose was more effective than the 5 mg dose and the drug would probably be filed for approval at the higher dose. The Phase 3 trial included 1,395 patients treated at 103 centers in the United States, Poland and India.
"We are highly encouraged with the results of our Phase III trial and are working diligently to get our product approved for marketing as soon as possible," said CEO Ronald Prentki. "According to our market research there are more than 6 million cycles of chemotherapy administered each year in the U.S. We believe this equates to an annual market opportunity in excess of $1 billion."
- read the A.P. Pharma release