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news.Agile Therapeutics, specialized in developing women's contraceptive products, has completed the final Phase III clinical trial of AG200-15, a combination hormonal contraceptive patch.
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The company is also believed to be on track to submit the New Drug Application (NDA) for AG200-15 to the US Food and Drug Administration (FDA) during the first quarter of 2012.
AG200-15 is a combination hormonal contraceptive patch, that has demonstrated a low dose delivery of ethinyl estradiol, as well as a dose of levonorgestrel that is consistent with the efficacy and safety profile of low-dose oral contraceptives.
Agile Therapeutics commenced the Phase III clinical trials, New Choice Study and New Choice II, for AG200-15 in August 2010.
Agile Therapeutics Clinical Research and Development chief medical officer and vice president Marie Foegh said the company has locked the last database and is initiating statistical analysis on the data from the study.
"We are on track to submit the NDA to the FDA during the first quarter of 2012 and look forward to working with the agency in 2012," Foegh added.