Moreover, AG200-15 with SKINFUSION(TM) technology allows for stable drug delivery and dependable adhesion over 7 days. AG200-15 is a 28 day regimen, with a patch worn once weekly for 3 weeks, with the fourth week off.
AG200-15 promises to be a safe, effective and low dose contraceptive option that will meet a major, unmet market need of convenience (i.e. not needing to take a pill everyday). The only marketed contraceptive patch in the U.S. has an FDA-mandated warning that informs patients of its increased exposure to estrogen. Specifically, patients using that contraceptive patch are exposed to 60 percent more estrogen than typical oral birth control pills.
"As elevated levels of estrogen have been linked to an increased risk of cardiovascular events like venous thromboembolism, the sales of this contraceptive patch have declined noticeably with increased awareness," notes Symank. "In contrast, AG200-15 delivers a low-dose of estrogen, which is less than half the dose of the currently marketed transdermal patch."
In Phase II clinical trials, AG200-15 demonstrated estrogen levels that were equivalent to low dose OCs. In addition to its excellent safety profile, AG200-15 is also designed to be effective in preventing pregnancy. In Phase II clinical trials, AG200-15 was found to suppress ovulation similar to a low-dose OC. Accordingly, this product is moving into Phase III clinical trials.
Agile Therapeutics is also developing a weekly, levonorgestrel (progestin)-only contraceptive patch, AG1000. The company has signed a clinical trial agreement with the National Institutes of Health (NIH) Eunice Kennedy Shriver National Inst
|SOURCE Frost & Sullivan|
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