Heron Therapeutics Inc. (HRTX)

[crammerfool]

A.P. Pharma Due off Extended-Hours Halt at 7:30 a.m. ET - Gets Response Letter from FDA on NDA, Agency Expresses Concerns, Details Other Issues 03/19 07:11 AM



07:11 AM Eastern Daylight Time, 03/19/2010 (MidnightTrader) -- A.P. Pharma (APPA:$2.06,00$0.50,0032.05%) announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). APF530 is a long-acting formulation of granisetron utilizing the Company's proprietary Biochronomer drug delivery system.
The FDA expressed concerns relating to A.P. Pharma's two-syringe administration system. The agency identified certain deficiencies during inspections of the company's contract manufacturing facilities; it requested the company change to terminal sterilization prior to approval; and requested clarification and revision of certain analytical specifications proposed in the company's NDA.
The FDA did not request additional clinical efficacy studies, although it did ask for the re-presentation and re-analysis of select existing Phase 3 clinical trial data. The FDA requested the company perform two studies relating to bioavailability and metabolism. A.P. Pharma believes these studies should be of short duration in normal volunteers. The FDA did not accept the company's request to waive the requirement for a thorough QT study. A.P. Pharma believes this study should be of short duration in normal volunteers. The company plans to discuss the design and timing of the study with the FDA.
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