FDAnews
www.fdanews.com/articles/97459-acura-secures-funding-for-oxyadf-trial

Acura Secures Funding for OxyADF Trial

August 21, 2007

Acura Pharmaceuticals announced it has entered into a securities purchase agreement that will allow it to fund Study 105, the pivotal Phase III trial for OxyADF tablets, a treatment for acute, moderate-to-severe postoperative pain following bunionectomy surgery in adult patients. 

According to Acura, Study 105 is a randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of the safety and efficacy of OxyADF Tablets (oxycodone HCl and niacin). 

The three-arm clinical trial will compare two dose levels of OxyADF tablets with placebo. Medication will be administered to patients every six hours for 48 hours following pain onset, the company said. 

The company added that Study 105 is targeted to enroll 135 patients per arm.