ALPHARETTA, Ga., Sept. 20, 2021 /PRNewswire/ -- Avion Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced the addition of Divigel® (estradiol gel) 0.1%–the #1 prescribed transdermal estrogen gel*–to the company's growing women's health portfolio.
"The addition of a well-established, trusted treatment for the symptoms of menopause complements our existing portfolio of prenatal care and oral contraceptive options and gives Avion the ability to provide women with treatment options through all stages of their lives," said Michael Sullivan, president of Avion.
According to the National Center for Biotechnology Information, 1.3 million women enter menopause each year in the United States, typically around age 51, and approximately 75% will experience vasomotor symptoms or "hot flashes" that can be unpredictable and disruptive to their lives.
Divigel is available in five strengths, including the lowest FDA-approved dose of transdermal estradiol gel or spray-0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, and 1.25 mg estradiol-allowing healthcare providers the ability to tailor treatment for their individual patient's needs. The product is supplied in a discreet gel pack and is applied once daily to a small area of the upper thigh.
As a part of their observance of Menopause Awareness Month, Avion will present a product theater on Friday, Sept. 24, during the North American Menopause Society Annual Meeting in Washington, DC. The product theater highlights the importance of meaningful conversations where healthcare providers and today's women, who expect to continue leading active and fulfilling lives through menopause and beyond, decide together if hormone therapy may be right for each woman's individual treatment goals.
Brooke Faught, the clinical director of the Women's Institute for Sexual Health in Nashville, Tenn., who will lead the product theater, emphasized, "Engaging with patients to understand how the often-disruptive symptoms of menopause are impacting their busy lives and then partnering with them to find effective treatment options is essential for today's generation of women."
"We remain deeply committed to being a leader in the field of women's health and will continue to add products to our portfolio that can make a meaningful difference to healthcare providers and patients alike," added Art Deas, CEO of Avion.
*Estimate derived from sales data (through July 2021) licensed from IQVIA information service NPA™.
INDICATION & IMPORTANT SAFETY INFORMATION
Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER
See Full Prescribing Information for complete Boxed Warning
- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
- Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia
- The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
- The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older
- Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known.
Estrogen Plus Progestin Therapy
- Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia
- The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age)
- The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older
- The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
- Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestin products is not known.
Prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
You may report suspected adverse reactions to Vertical Pharmaceuticals, LLC at 1-877-482-3788 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see additional Important Safety Information and Full Prescribing Information, including Boxed Warning and Patient Counseling Information, available at www.divigel.com/hcp. For more information, call 1-866-600-4799 or visit www.divigel.com.
About Avion Pharmaceuticals, LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical company formed to develop, acquire, and market a portfolio of innovative pharmaceutical products in women's health and other therapeutic categories aligned with our mission to improve the quality of patients' lives. Avion Pharmaceuticals focuses on identifying opportunities to develop, acquire, and enhance the market potential of innovative, commercially available therapeutics and late-stage-development drugs to fulfill unmet medical needs. For additional information about Avion Pharmaceuticals, please contact the company at 1-888-612-8466. For more information, visit www.avionrx.com.
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