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news.US-based specialty pharmaceutical company Agile Therapeutics has successfully completed two key clinical trials in the development of the company's new, low-dose, once-weekly, contraceptive patch, which the company refers to by its internal product code AG-200-15.
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The Phase IIb safety and efficacy study successfully met its primary endpoint of ovulation suppression, cycle control and safety, the company said. The pharmacokinetic (PK) study demonstrated estrogen levels comparable with the well-established, low-dose oral contraceptive, Levlen. There were no serious adverse events in either study.
The PK study was an open-label, randomized, comparative, single-center, two-period cross-over study with 39 patients that evaluated two contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral contraceptive, Levlen. As intended, both the EE and LNG exposure over time of both patches were less than Levlen and consistent with the levels targeted by the company.
In the multi-centered, multi-cycle Phase IIb safety and efficacy study of 123 women, the company studied patches with different estrogen and progestin doses for three cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose.
Top-line results from the trial showed there was a clear dose-response to ovulation suppression and cycle control. AG-200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied, the company said.
Thomas Rossi, Agile’s president and CEO, said: “Based upon these results, we have been able to select AG-200-15 as our candidate for Phase III development. We are looking forward to discussing our results with the FDA and solidifying our Phase III plan.”