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A.P. Pharma submits anti-nausea drug for FDA approval

A.P. Pharma submits anti-nausea drug for FDA approval

APF530 is undergoing regulatory review for a new drug approval for the prevention of chemotherapy-induced nausea and vomiting, according to manufacturer A.P. Pharma. PF530 is a formulation of granisetron, a 5-HT3 antagonist.

The drug is delivered using the company’s Biochronomer system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection.

In a phase III, randomized, multicenter trial of 1,395 cancer patients, APF530 was shown to be as effective as palonosetron (Aloxi) for the prevention of acute onset and delayed onset CINV, A.P. Pharma said in a statement.

 
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