{"id":394119,"date":"2020-12-07T07:33:14","date_gmt":"2020-12-07T12:33:14","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=394119"},"modified":"2020-12-07T07:33:14","modified_gmt":"2020-12-07T12:33:14","slug":"agile-therapeutics-announces-nationwide-commercial-launch-and-availability-of-twirla-levonorgestrel-and-ethinyl-estradiol-transdermal-system-a-new-non-daily-non-invasive-contraceptive-patch","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/agile-therapeutics-announces-nationwide-commercial-launch-and-availability-of-twirla-levonorgestrel-and-ethinyl-estradiol-transdermal-system-a-new-non-daily-non-invasive-contraceptive-patch\/","title":{"rendered":"Agile Therapeutics Announces Nationwide Commercial Launch and Availability of Twirla\u00ae (levonorgestrel and ethinyl estradiol) Transdermal System, a New Non-Daily, Non-Invasive Contraceptive Patch"},"content":{"rendered":"
\n

\n Once-Weekly<\/em>
\n Twirla is the first and only contraceptive patch that combines levonorgestrel and ethinyl estradiol (EE)<\/em>\n <\/p>\n

PRINCETON, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc. (Nasdaq: AGRX), a women\u2019s healthcare company, today announced the U.S. commercial launch of Twirla\u00ae<\/sup> (levonorgestrel and ethinyl estradiol) transdermal system, a new non-daily, non-invasive contraceptive patch. Twirla is now available in the United States by prescription for women of reproductive potential with a body mass index (BMI) <30 kg\/m2<\/sup> for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. Twirla is less effective in women with a BMI \u2265 25 kg\/m2<\/sup> to < 30 kg\/m2<\/sup> and should not be used in women with a BMI \u2265 30 kg\/m2<\/sup>.\u00a0\u00a0<\/p>\n

Please see Important Safety Information for Twirla, including BOXED WARNING on Cigarette Smoking and Serious Cardiovascular Events and Contraindication in Women with a BMI \u2265 30 kg\/m2<\/sup>, below in \u201cAbout Twirla.\u201d In a clinical trial, the most common adverse events were skin reactions at the patch site, nausea, headache, menstrual cramps, and weight gain.<\/p>\n

\u201cWe are thrilled to launch our first commercial product, Twirla, an effective, modern contraceptive option, for women and their healthcare providers,\u201d said Al Altomari, Chairman and Chief Executive Officer of Agile. \u201cFamily planning experts believe the most successful contraception for a woman is one of her choosing that fits her lifestyle, and we believe Twirla will be a valuable addition to the category\u2019s available options. We are committed to seeking ways to make Twirla affordable and accessible for women.\u201d<\/p>\n

Twirla is worn weekly and delivers a 30 mcg daily dose of ethinyl estradiol, the lowest exposure of estrogen in a transdermal contraceptive option1<\/sup>, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin with a long history of use in the category. Twirla is designed to be worn on the abdomen, buttock, or upper torso (excluding the breasts), using Skinfusion\u00ae<\/sup> technology. At less than 1mm thin, Twirla is made up of five distinct layers for focused drug delivery and to help maintain adhesion. \u00a0\u00a0<\/p>\n

\u201cNearly all women use contraception at some point in their lives, but when it comes to preventing unplanned pregnancies, 90% of failures are attributed to inconsistent and\/or improper use,\u201d said Donnica Moore, MD, women\u2019s health expert and advocate, President, Sapphire Women\u2019s Health Group and consultant to Agile Therapeutics. \u201cToday, women need a birth control product that is not only safe and reliable, but also that fits seamlessly into an active lifestyle. The soft and flexible design of Twirla contours to a woman\u2019s body, requires no invasive procedures, and reduces the burden of daily administration. I am excited that healthcare providers can now offer a new solution that can fill a gap in hormonal contraceptive care.\u201d<\/p>\n

\u201cThe approach that we have taken in the development and launch of Twirla is representative of Agile\u2019s ongoing dedication to addressing the unmet needs of today\u2019s women,\u201d said Paul Korner, MD, MBA, Chief Medical Officer of Agile. \u201cNot only did we design our Phase 3 trial to closely represent the U.S. demographics of women, but we also worked with women over the last four years to better understand their evolving needs to ensure our patient programs holistically support women who use Twirla.\u201d<\/p>\n

To provide women with additional personalized resources, Agile has introduced an insight-driven experience, called The Loop<\/em> (http:\/\/www.Twirla.com\/TheLoop<\/a>). The Loop<\/em> will serve as an online destination where women can get meaningful resources as they navigate their birth control journeys. Twirla patients can access the Twirla patch replacement program, chat with qualified nurse-educators about patch use, and read specially curated content designed to inspire Twirla women beyond the brand. The Loop<\/em> is designed to create a sense of community by bringing together and celebrating women who embody the Twirla spirit of courage and confidence.<\/p>\n

Women who would like to learn more about Twirla as a potential contraceptive option should speak to their doctor or a healthcare provider. For more information on Twirla, consumers and healthcare providers can visit www.Twirla.com<\/a>.<\/p>\n

\n 1<\/sup>Xulane [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; 2020.\u00a0\u00a0<\/p>\n

\n About Twirla<\/strong>
\n
\n IMPORTANT SAFETY INFORMATION<\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n
\n WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI \u2265 30 KG\/M<\/strong>
\n
\n 2<\/strong>
\n <\/sup>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
\n
\n Cigarette Smoking and Serious Cardiovascular Events<\/strong>
\n <\/u>\n <\/td>\n<\/tr>\n
\n Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.<\/strong>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
\n
\n Contraindicated in Women with a BMI \u2265 30 kg\/m<\/strong>
\n <\/u>
\n
\n
\n 2<\/strong>
\n <\/u>
\n <\/sup>\n <\/td>\n<\/tr>\n
\n TWIRLA is contraindicated in women with a BMI \u2265 30 kg\/m<\/strong>
\n
\n 2<\/strong>
\n <\/sup>
\n . Compared to women with a lower BMI, women with a BMI \u2265 30 kg\/m<\/strong>
\n
\n 2 <\/strong>
\n <\/sup>
\n had reduced effectiveness and may have a higher risk for venous thromboembolism events (VTEs).<\/strong>\n <\/td>\n<\/tr>\n<\/table>\n

\n CONTRAINDICATIONS
<\/strong>TWIRLA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic disease, including women with a BMI \u2265 30 kg\/m2<\/sup>; have headaches with focal neurological symptoms, migraine with aura, women over 35 years of age with any migraine headache; liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; hypersensitivity to any components of TWIRLA; and use of Hepatitis C drug combinations containing ombitasvir\/paraparesis\/ritonavir with or without dasabuvir.<\/p>\n

\n WARNINGS AND PRECAUTIONS<\/strong>\n <\/p>\n