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FDA approves Agile Therapeutics Inc’s Twirla contraceptive patch

Twirla is a new non-daily, non-invasive contraceptive approved in the United States

Agile Therapeutics - FDA approves Agile Therapeutics Inc’s Twirla contraceptive patch
The New Jersey-based company is providing women with a contraception option beyond the birth-control pill

Agile Therapeutics Inc (NASDAQ:AGRX) announced Tuesday that the US Food and Drug Administration (FDA) has approved Twirla, a new non-daily prescription contraceptive.

The low-dose prescription contraceptive is delivered through the skin through the company’s proprietary patch technology called Skinfusion and its active ingredients are ethinyl estradiol, a synthetic estrogen, and levonorgestrel, a type of progestin. The new weekly contraceptive patch delivers a 30 mcg daily dose of estrogen and 120 mcg daily dose of progestin, said the company.

In a statement, the Princeton, New Jersey-based company said Twirla is a method of contraception for use in women with a body mass index (BMI) < 30 kg/m2,  for whom a combined hormonal contraceptive is appropriate. 

READ: Agile arranges $35M financing deal as lead product Twirla awaits FDA approval

The company noted that one had to consider Twirla’s reduced effectiveness in women with a BMI > 25 to < 30 kg/m2 before prescribing. Similarly, Twirla is contraindicated in women with a BMI > 30 kg/m2.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate US women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives,” said Dr David Portman, a primary investigator on the SECURE clinical trial.

“I’m pleased that Agile conducted a comprehensive study in a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle. I am excited healthcare providers can now include Twirla among available contraception options.”

Designed for weekly application

Twirla is designed for weekly application to deliver a 30 mcg daily dose of ethinyl estradiol, a type of estrogen, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin with a long history in the category.

The newly approved patch can be worn on the abdomen, buttock, or upper torso (excluding the breasts), pointed out the company.

Agile Therapeutics CEO Al Altomari said that the FDA’s approval of Twirla would enable the company to deliver on its short-term goal of establishing Agile in the contraceptive prescription market and working towards its longer-term mission to broaden the firm’s women’s health portfolio, including in areas of unmet need.

“We are grateful to the clinical trial patients, researchers, healthcare providers, and advocates, whose contributions helped us secure the approval of a new transdermal contraceptive option that may serve the contraceptive needs and preferences of many women,” said Altomari.

"We are proud to offer this new option and look forward to bringing Twirla to women and their healthcare providers.”

As part of Twirla’s approval, the FDA is requiring Agile to conduct a long-term prospective, observational post-marketing study comparing the risks for venous thromboembolism (VTE) and arterial thromboembolism (ATE) in new users of Twirla to new users of other combined hormonal contraceptives (CHC). 

The FDA’s requirement for Twirla is similar to another post-marketing study requirement for a recently approved CHC. The final study report for the Twirla study is scheduled to be submitted to the FDA in November 2032, with interim safety data reporting to the FDA due in November 2026.

Agile has also agreed to a post-marketing commitment study to assess the residual drug content and strength of Twirla in a minimum of 25 women, which will analyze the Twirla ethinyl estradiol and levonorgestrel content after the prescribed wear and will monitor adhesion. The PMC is similar to residual drug studies requested of patch developers in the FDA’s November 2019 draft guidance entitled “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations.” The company plans to begin designing the post-approval studies and evaluating related costs during the first half of 2020.

Accelerating commercial activities

With the approval of Twirla, Agile said it will “accelerate” its commercial activities. In the first quarter of 2020, Agile plans to initiate work with managed care and patient payors to gain market access for Twirla. Beginning in the second quarter of 2020, the company plans to hire and train an initial sales team. Agile has earlier said it intends to commercialize the product in the US through a direct sales force of 70 to 100 representatives that will target obstetricians and gynecologists, nurse practitioners, physician assistants and primary-care providers.In parallel with these activities, Agile plans to complete the validation of its commercial manufacturing process and expects to ship initial product to wholesalers in the fourth quarter of 2020.

The company said it believes that the potential new CHC users who have a BMI <30 kg/m2 represent a “significant population of women.” Based on the company’s market research, analysis of the US contraceptive market, and review of other product launches in the category, the company estimates that Twirla can potentially achieve a peak market share of 5-8%.

The stock was trading at $3.9 before the opening bell.

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Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

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NASDAQ:AGRX
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Agile Therapeutics looks forward to Feb 16 PDUFA date

Agile Therapeutics (NASDAQ:AGRX) CEO Al Altomari sat down with Proactive’s Christine Corrado at the Biotech Showcase 2020 in San Francisco. New Jersey-based Agile is focused on seeking FDA approval of its lead drug Twirla, and is looking forward to its Feb 16 PDUFA date

on 01/14/2020

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