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TJSL Capsules Phase III Trial Enrollment Ahead Of Schedule: Aoxing

Aoxing Pharmaceutical has recruited over 120 patients in its oral TJSL Capsules 12-week, multi-center, randomised, double-blind and active-controlled Phase III clinical studies. Aoxing said that the enrollment process is expected to be completed ahead of the schedule by December 2010.

The current study was initiated to evaluate the safety and efficacy of TJSL Capsules among 440 patients with primary dysmenorrheal.

TJSL Capsules is a novel investigational drug to treat primary dysmenorrhea (PD), or menstrual pain, in adult women.

Aoxing Pharma initiated this Phase III program in March 2010, following the successful completion of Phase II trial in January 2010.

The Phase II trial demonstrated that the investigational TJSL Capsules were safe and efficacious among 240 patients with primary dysmenorrheal during the 12-week, multi-center, randomised, double-blind and placebo-controlled trial.

Zhenjiang Yue, chairman and CEO of Aoxing Pharma, said: “We are very thrilled to report the swift progress of our Phase III clinical trial as it advances TJSL Capsules one step closer to becoming a potential new treatment option for patients with primary dysmenorrheal.”