The FDA threw A.P. Pharma a curveball when the agency issued the company a rejection letter detailing problems with its sustained-delivery treatment for chemotherapy-induced nausea and vomiting.
A.P. submitted an NDA to the agency in September 2012 for its delayed-onset injectable treatment, APF530, which makes use of a delivery system that significantly extends the active life of the antagonist granisetron. The company's own polymer-based Biochronomer delivery platform is at the heart of the new chemotherapy drug, allowing for only one injection every 5 days rather than once or twice per day, according to a release.
But the FDA responded in turn with a letter to A.P., requesting several changes be made to the drug before consideration. Among the agency's concerns are the quality of materials at the manufacturing level, the need for further studies regarding the syringe system and the classification of Phase III trials with regard to chemotherapy type.
To address these concerns, A.P. will push its projected launch of the drug to the first half of 2014, rather than the original projection of early this year, according to a statement from A.P. CEO John B. Whelan.
The need for a chemotherapy-management drug is great, though, with only one other injectable version on the market, and the regimen of just one injection every 5 days is an improvement on existing daily treatments.
- here's the release