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PRINCETON, NJ, May 05, 2022 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today released the results of its first year of safety monitoring post-marketing pharmacovigilance for Twirla® (levonorgestrel and ethinylestradiol) transdermal system (LNG/EE TDS).
The contraceptive transdermal delivery system was approved by the United States Food and Drug Administration (“FDA”) in February 2020 as a method of contraception for use in women of childbearing potential with a body mass index (BMI) 2. Approval of the LNG/EE TDS was based on the SECURE study, which demonstrated safety in a large, diverse group of women in a clinical trial. The current evaluation provides an update on the safety of LNG/EE TDS based on real-world post-marketing adverse event reports.
Prescriptions for LNG/EE TDS were dispensed during this post-marketing period – from December 2020 to December 2021 – with additional patches dispensed as samples (for a total of approximately 11,000 woman-years). No venous thromboembolic events (VTEs) were reported and two serious adverse events (SAEs) were reported, results which are consistent with the safety profile reported in the SECURE study.
“These real-world usage data in a diverse U.S. population further support the safety and tolerability profile of Twirla established in the SECURE clinical trial,” said Paul Korner, MD, MBA, Chief Medical Officer of Agile Therapeutics.
In addition to the safety results, reports of TDS adhesion issues were rare, and only 14 people received a replacement patch during the 12 month period.
“As an investigator and clinician, it is encouraging to see that the safety and tolerability profile of Twirla in the first year of real-world use is consistent with the results of the Phase SECURE trial. 3. This level of data transparency and commitment to providing information to clinicians can further enable them to make informed decisions with their patients,” said Robin Kroll, MD, FACOG, investigator of the SECURE trial.
The poster, titled Post-marketing safety of a levonorgestrel/ethinyl estradiol transdermal contraceptive delivery systemwas written by Robin Kroll, MD, Andrew M. Kaunitz, MD, FACOG, Beata Teixeira de Mattos, Joseph A. Chiodo III, PharmD, Michelle L. Previtera, PhD, and Paul Korner, MD, MBA and will be available for meeting participants in person, via the ACOG website at https://www.acog.organd the CAGP journal website, greenjournal.org from May 5, 2022.
Tourbillon® (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestogen, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated as a method of contraception in women of childbearing potential with a body mass index (BMI) of 2 for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider the reduced effectiveness of Twirla in women with a BMI ≥ 25 to 2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in women over 35 who smoke. Smoking increases the risk of serious cardiovascular events related to CHC use. Twirla is designed to be applied once a week for three weeks, followed by a patch-free week.
About Agile Therapeutics, Inc.
Agile Therapeutics is a forward-thinking women’s healthcare company dedicated to addressing the unmet health needs of women today. Twirla and our product candidates are designed to provide women with contraceptive options that allow them to skip the daily pill, without committing to a long-acting method. Tourbillon® and our pipeline products are based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company’s website at www.agiletherapeutics.com. The Company may occasionally release material, non-public information on the Company’s website.
Certain information in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, relating to our regulatory submissions. and security profile for Twirla. We may, in some cases, use terms such as “predicts”, “believes”, “potential”, “continues”, “anticipates”, “estimates”, “expects”, “plans”, “has ‘intent to’, ‘may’, ‘could’, ‘might’, ‘probable’, ‘will’, ‘should’ or other words that convey uncertainty about future events or results to identify these forward-looking statements. Our forward-looking statements are based on the current beliefs and expectations of our management team which involve risks, potential changes in circumstances, assumptions and uncertainties, including statements regarding the market availability of Twirla and the consistency of Twirla’s security profile over time. Any or all of the forward-looking statements may prove to be inaccurate or be affected by inaccurate assumptions that we may make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties, including risks relating to our ability to maintain regulatory approval of Twirla, the continued adoption of Twirla in a broader patient population, the possibility that Twirla may develop unexpected changes in safety, efficacy or quality, our ability to successfully commercialize Twirla, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and direction, and other risks set forth in our filings with the US Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all of these reasons, actual results and developments could differ materially from those expressed or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances.