A.P. Pharma, Inc. has announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system.
"The submission of this NDA marks a significant milestone for the APF530 program, our Biochronomer drug delivery technology and A.P. Pharma as a company," said Ronald J. Prentki, A.P. Pharma's president and chief executive officer. "Our number-one priority has been to assemble and submit a complete and high-quality NDA. We thank our regulatory, CMC, clinical and e-filing experts for their tireless efforts and look forward to a timely review by the FDA."
"The favorable efficacy and safety demonstrated in the APF530 Phase 3 clinical program provides a strong foundation for our submission," stated Mr. Prentki. "We believe APF530, which maintains therapeutic drug levels for five days, will be a 'long acting' agent offering important advantages over anti-emetics currently used in the prevention of CINV, and would provide a particular benefit to those many patients suffering with delayed onset nausea and vomiting."
The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron. The FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the Company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the Prescription Drug User Fee Act guidelines, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following NDA submission.