A.P. Pharma granisetron formulation delay
This article was originally published in Pharmaceutical Approvals Monthly
Redwood City, Calif.-based A.P. Pharma expects to submit an NDA for its novel formulation of the antiemetic granisetron (Roche's Kytril and generics) by the end of 2007. The firm had expected initial Phase III data in Q1 2007, but is revising that timing to the second half of next year "due to a slower-than-expected start in getting IRB approvals and clinical sites prepared to begin enrolling patients, and in recruiting patients during the summer months." The firm's formulation of the established 5-HT3 antagonist employs a proprietary Biochronomer bioerodible drug delivery system...
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