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Article: Other News To Note.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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o Acura Pharmaceuticals Inc., of Palatine, Ill., said it reached agreement with the FDA on a special protocol assessment for a pivotal Phase III trial of OxyADF tablets. The FDA previously communicated to the company that only one successful Phase III pivotal study would be required prior to NDA submission. The pivotal trial, AP-ADF-105, will evaluate OxyADF (oxycodone HCl and niacin) in the treatment of pain following bunionectomy surgery in adults. The 405-patient study will compare two drug doses to placebo. Enrollment remains dependent upon the company's ability to secure near-term funding, as its current cash will fund operations only through mid-July, Acura said.
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... ... following news that the San Diego-based company hadstatistically significant Phase III data for its lead diabetes ... The company reported the Phase III study of the drug, a syntheticanalogue ... that the U.S.-based Phase III studies would showstatistical ...
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