Twirla® is a new non-daily, non-invasive contraceptive approved in the U.S.
PRINCETON, NJ, USA I February 14, 2020 I Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Twirla® (levonorgestrel and ethinyl estradiol) transdermal system.
INDICATION AND USAGE
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use
Consider TWIRLA’s reduced effectiveness in women with a BMI > 25 to < 30 kg/m2 before prescribing. TWIRLA is contraindicated in women with a BMI > 30 kg/m2.
Please see Important Safety Information for TWIRLA, including BOXED WARNING on Cigarette Smoking and Serious Cardiovascular Events and Contraindication in Women with a BMI > 30 kg/m2, below in “About Twirla.”
“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. 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.”
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).
“The FDA’s approval of Twirla will enable us to deliver on our short-term goal of establishing Agile in the contraceptive prescription market and working towards our longer-term mission to broaden our 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 Al Altomari, chairman and chief executive officer, Agile Therapeutics. “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 (PMC) 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.
With the approval of Twirla, Agile 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. 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 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 current and expected future U.S. 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%. As the Company prepares for the commercialization of Twirla, it will continue to analyze the contraceptive market and update its market research as it evaluates the commercial opportunity for Twirla.
INDICATIONS AND USAGE
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use:
Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m2.
This is not a comprehensive list of safety information related to TWIRLA.
Please See Full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.
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.
SOURCE: Agile Therapeutics
Post Views: 141
Twirla® is a new non-daily, non-invasive contraceptive approved in the U.S.
PRINCETON, NJ, USA I February 14, 2020 I Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Twirla® (levonorgestrel and ethinyl estradiol) transdermal system.
INDICATION AND USAGE
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use
Consider TWIRLA’s reduced effectiveness in women with a BMI > 25 to < 30 kg/m2 before prescribing. TWIRLA is contraindicated in women with a BMI > 30 kg/m2.
Please see Important Safety Information for TWIRLA, including BOXED WARNING on Cigarette Smoking and Serious Cardiovascular Events and Contraindication in Women with a BMI > 30 kg/m2, below in “About Twirla.”
“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. 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.”
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).
“The FDA’s approval of Twirla will enable us to deliver on our short-term goal of establishing Agile in the contraceptive prescription market and working towards our longer-term mission to broaden our 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 Al Altomari, chairman and chief executive officer, Agile Therapeutics. “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 (PMC) 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.
With the approval of Twirla, Agile 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. 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 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 current and expected future U.S. 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%. As the Company prepares for the commercialization of Twirla, it will continue to analyze the contraceptive market and update its market research as it evaluates the commercial opportunity for Twirla.
INDICATIONS AND USAGE
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use:
Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m2.
This is not a comprehensive list of safety information related to TWIRLA.
Please See Full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.
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.
SOURCE: Agile Therapeutics
Post Views: 141
