Agile Therapeutics has concluded the final Phase III clinical trial of AG200-15, the company's hormonal contraceptive patch containing ethinyl estradiol in combination with levonorgestrel.
AG200-15 is a combination low-dose weekly contraceptive patch, which has been proven to deliver doses of ethinyl estradiol and levonorgestrel that are consistent with the efficacy and safety profile of low-dose oral contraceptives.
The patch uses Skinfusion, Agile's proprietary transdermal delivery technology. It is designed to be applied once weekly for three weeks, followed by a patch-free fourth week.
It can be applied to the abdomen, buttocks or upper torso, and is soft and flexible with a cloth-like, silky feel, the company said.
Agile Therapeutics clinical research and development vice-president and chief medical officer Marie Foegh said that 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 new drug application to the US Food and Drug Administration during the first quarter of 2012 and look forward to working with the agency in 2012," Foegh added.
An earlier Phase II open-label, crossover study compared ethinyl estradiol's pharmacokinetic profile in AG200-15 to an oral contraceptive in healthy female volunteers. It found that AG200-15 delivers a daily oestrogen equivalent to 30µg of ethinyl estradiol, comparable to a low-dose oral contraceptive.
The study also demonstrated that the maximum plasma concentration level was approximately 60% lower for AG200-15, and steady-state concentration levels were 15%-20% lower for AG200-15 compared to a 35µg of an oral contraceptive.
The Phase II study also reported the safety and tolerability profile of AG200-15 in addition to data on ovulation in obese and non-obese women.