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(EMAILWIRE.COM, March 13, 2010 )NY,NY TapeBeat.Com, the news and research portal for the serious investor is proud to present information regarding A.P. Pharma, Inc., (Public, NASDAQ:APPA) a specialty pharmaceutical company based in Redwood City, California. Its current pipeline utilizes a group of polymeric compounds dubbed Biochronomer as its drug delivery mechanism with a number of advantages over current delivery means. Probably the most important advantage of the Biochronomer system is that the actives (drugs) can be incorporated into a drug matrix by simple physical mixing means that allow injectable gels, microspheres, coatings and strands to be created depending on the necessary application. Each of these different forms is capable of controlling site and speed of the active ingredient delivery without the use of active and sometimes questionable liquids such as solvents in the finished drug product.
Currently there is only one drug approved for both acute and delayed onset CINV via serotonin 5-HT3 antagonists, Palonosetron. Serotonin 5-HT3 antagonists work by blocking the effects of a chemical called serotonin, which is produced in the brain and stomach. They prevent and relieve nausea and vomiting caused by chemotherapy. APF530 works by utilizing its delivery system and the 5-HT3 receptor antagonist, Granisetron, as its active ingredient. Granisetron was approved by the FDA for the treatment of acute onset CINV in 1994. The patent on it expired in 2007, so it is freely available for use in APF530.
An advantage of utilizing a previously-approved active ingredient is that the NDA can be submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act in which the application can rely upon the FDAÂ’s previous safety and efficacy profile for APF530Â’s active ingredient. For further information on how this may favor approval of APF530 please visit TapeBeat.Com for the full story.
Stephen Ramsey
Philip Runfeldt
Staff Writers
Mr. Ramsey is long APPA
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