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The Company’s lead product, APF530, is being developed for the prevention of CINV in patients receiving either moderately or highly emetogenic chemotherapy. APF530 is delivered by a single subcutaneous injection and contains the 5-HT3 antagonist, granisetron. Granisetron, for infusion and oral tablets, is approved for the prevention of acute onset CINV, but not delayed onset CINV. We selected granisetron because it is a potent drug and the applicable granisetron patent expired in the United States on December 29, 2007.
Granisetron and other 5-HT3 antagonists, as a class, have become the most common antiemetic agents used in chemotherapy. However, no 5-HT3 antagonist formulation is currently approved for the prevention of both acute and delayed onset CINV for both moderately and highly emetogenic chemotherapy. A.P. Pharma's APF530 Phase 3 clinical trial demonstrated that it can deliver therapeutic levels of granisetron to prevent acute onset CINV for both moderately and highly emetogenic chemotherapy, and to prevent delayed onset CINV in moderately emetogenic chemotherapy. The sector efficacy data involving delayed onset CINV in highly emetogenic chemotherapy showed results for the higher dose of APF530 that were numerically better than palonosetron and statistically non-inferior, but did not achieve the statistically significant level of superiority necessary to support a claim in this sector. If A.P. Pharma obtains product approval for all uses except the delayed onset highly emetogenic one, the Company should have a product comparable to palonosetron, which despite the limitation of its claim for prevention of delayed onset CINV to only moderately emetogenic treatments, has achieved considerable commercial success.
In May 2009, A.P. Pharma submitted an NDA for APF530 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. T
More Info about APF530
| Drug Type: | Other |
| Current FDA Status: | Pending Decision |
| Current Drug Phase: | NDA |
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