Friday, March 25, 2011

Trial Updates

Drug Approval News:

You have helped move medicine forward!!! 

The FDA has approved the Shingles Vaccine (Zostavax) for patients 50 and older!  This vaccine is already approved for patients 60 and older.  The PMG Research network has done multiple trials with Zostavax and would like to thank all of the participants and sites that helped to conduct the research for Zostavax to allow it to be approved for a younger age group. For more information about this report, click here.

The FDA also approved Takeda's drug Edarbi to treat high blood pressure.  The FDA concluded that "the newly approved agent was more effective in clinical studies than two other FDA-approved ARB's, valsartan (Diovan) and olmesartan (Benicar)."  PMG Research would like to thank all of the volunteers and PMG sites that participated in the trials that helped get this important drug approved.  Learn more about Edarbi for high blood pressure here.

Other trial news:

The FDA has granted fast track designation to Furiex' drug for Irritable Bowel Syndrome.  Fast track designation allows the development and approval process to be expedited for drugs that are intended to treat serious or life-threatening conditions or address unmet medical needs.  Several PMG sites are currently involved in trials for this IBS drug, MuDelta.  Furiex Chief Medical Officer says "We believe we are making significant progress with the Phase II trial, and this designation allows us to potentially get MuDelta to market faster."  Learn more about MuDelta.

BioSante reports positive results for treatment to treat low libido in post-menopausal women.  BioSante hopes this medication will become the first treatment to boost sex drive in post-menopausal women.  PMG Research is currently involved in conducting trials for the development of LibiGel.  Learn more about the trial results for LibiGel here.

Auxilium Pharmaceuticals announced that enrollment has been met in the Xiaflex Phase III program for Peyronie's Disease.  PMG Research has contributed to enrollment in Xiaflex development program.  Auxilium says that enrollment of these patients so quickly indicates "enthusiasm in the urology community and their prospective patients for a non-surgical treatment alternative."  Learn more about Xiaflex.

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