Agile Therapeutics® Announces Poster Presentation at the 2022 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG)

Rhea-AI Summary

Agile Therapeutics (Nasdaq: AGRX) announced that data from its first-year postmarketing pharmacovigilance safety surveillance for Twirla (levonorgestrel and ethinyl estradiol) will be presented at the 2022 ACOG Annual Meeting from May 4-6, 2022. The company emphasized its commitment to patient safety and expressed encouragement regarding the first-year safety data. The poster presentation will be available to attendees and online after May 6, 2022. Twirla is a once-weekly contraceptive patch aimed at women with a BMI < 30 kg/m², with specific contraindications outlined.

Positive

• Presentation of Twirla safety data at the reputable ACOG Annual Meeting enhances visibility.
• Positive first-year postmarketing pharmacovigilance data reflects well on product safety.

Negative

• Twirla is contraindicated for women with a BMI ≥ 30 kg/m², limiting potential market.
• Efficacy concerns in patients with BMI ≥ 25 kg/m² may affect market perception.

The abstract was accepted by ACOG and will be presented from May 4th – May 6th, 2022

PRINCETON, N.J., April 07, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that data from the company’s first-year of postmarketing pharmacovigilance safety surveillance for Twirla^® (levonorgestrel and ethinyl estradiol) transdermal system, will be presented at the 2022 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting.

“Patient safety is a primary focus for Agile Therapeutics. We are encouraged by Twirla’s first-year post-marketing pharmacovigilance data and thought it important to share this information with the healthcare community,” said Paul Korner, MD, MBA, Chief Medical Officer of Agile Therapeutics.

The poster, entitled Postmarketing Safety of a Levonorgestrel/Ethinyl Estradiol Contraceptive Transdermal Delivery System, authored 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,^, will be presented by Robin Kroll, MD and will be available to meeting attendees in person and through the ACOG website at https://www.acog.org, beginning May 6, 2022.

About Twirla^®
Twirla^® (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 progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m² for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30 kg/m² before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m². Twirla is also contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from CHC use. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.  

About Agile Therapeutics, Inc.
Agile Therapeutics is a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of today’s women.  Twirla and our product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method.  Twirla^® 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 website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website.

Follow Agile on LinkedIn and Twitter: @AgileTher.

Forward-Looking Statement
Certain information contained 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, related to our regulatory submissions and safety reporting for Twirla. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding the safety profile of Twirla.  Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to our ability maintain regulatory approval of Twirla, the possibility that Twirla could develop unexpected safety, efficacy or quality concerns, 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 focus, and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q.  For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

FAQ

What is the significance of Agile Therapeutics presenting safety data for Twirla?

Presenting safety data at ACOG highlights Agile's commitment to patient safety and can enhance credibility.

When will the Twirla safety data be available to the public?

The safety data will be presented at the ACOG meeting from May 4-6, 2022, and will be available online starting May 6, 2022.

What are the contraindications for using Twirla?

Twirla is contraindicated in women with a BMI ≥ 30 kg/m² and in women over 35 who smoke.

How does Twirla's efficacy relate to body mass index?

Twirla is indicated for women with BMI < 30 kg/m², but its efficacy may be reduced in those with a BMI between 25 and 30 kg/m².