A.P. Pharma's shares went into a tailspin this morning after the FDA rejected the company's anti-nausea drug, a long-acting formulation of granisetron for chemo-induced vomiting. And the company was handed a long checklist of criteria it must meet before the FDA can approve APF530.
FDA has questions about the company's two-syringe administration system for APF530 and expresses concern that cross-contamination could occur between the syringes. The complete response letter also raises the possibility of improper administration of the drug. Additionally, the agency identified deficiencies at A.P. Pharma's manufacturing facilities--as well as at several of its contract manufacturing facilities--that will have to be resolved prior to approval.
While the FDA hasn't requested additional clinical efficacy studies, A.P. will be required to conduct two studies related to bioavailability and metabolism. Finally, the agency has refused to accept the company's request to waive the requirement for a QT study to examine APF530's impact on the heart's electrical cycle. Based on the additional data the company needs to submit, A.P. says in its release that its nausea drug won't be available in 2010.
- here's A.P. Pharma release
- see the Reuters report for more