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Investigational oral contraceptive patch offers comparable safety to approved products

NASHVILLE. Tenn. — Combined data from three phase 3 trials showed Agile Therapeutics’ investigational oral contraceptive patch AG200-15 had a safety profile similar to other approved contraceptives, according to data presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting.

AG200-15, also known as Twirla, delivers approximately 120 mg of levonorgestrel and 30 mg of ethinyl estradiol daily to users, according to Anita L. Nelson, MD, professor and chair of obstetrics and gynecology at Western University Health Sciences.

Researchers reported 54% of the 3,481 patients from the three trials reported an adverse event, with 26% of the adverse events were drug-related, 11% led to study discontinuation and 5% were of severe intensity. The most common adverse events included nasopharyngitis (5.7%), upper respiratory tract infection (4.5%), nausea (4.3%), headache (3.6%) and urinary tract infections (3.5%). Severe adverse events such as cholelithiasis, deep vein thrombosis, pulmonary embolism and depression occurred in less than 2% of patients, Nelson and colleagues wrote.

“The percentages of [treatment emergent adverse events] and [severe adverse events] were generally similar across the phase 3 studies. The adverse event profile of AG200-15 appears to be similar to approved [oral contraceptives],” Nelson and colleagues concluded.

Agile Therapeutics intends to resubmit its new drug application to the FDA in the second quarter of this year, according to a company press release. – by Janel Miller

References : Agile Therapeutics. “Agile Therapeutics reports fourth quarter and full year 2018 financial results.” https://ir.agiletherapeutics.com/news-releases/news-release-details/agile-therapeutics-reports-fourth-quarter-and-full-year-2018. Accessed April 24, 2019.

Nelson AL, et al. “Safety of AG200-15, an investigational transdermal patch, in three phase 3 studies.” Presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 3-6, 2019; Nashville.

Disclosures: Nelson and colleagues report many relevant financial disclosures. Please see the abstracts for specifics.