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Coming Soon: A Menopausal Solution That's Not All About Sex
PHILADELPHIA, Jan. 7, 2020 /PRNewswire/ -- FemmePharma has received clearance from the US Food & Drug Administration under Section 510(k) of the Food, Drug and Cosmetic Act to manufacture and bring to market its Satisfaite™ delivery system for the relief of vaginal symptoms of menopause affecting more than one in three women in the US alone.
With Satisfaite™, FemmePharma continues to deliver on its promise to change the face of women's menopausal health by developing innovative products that meet women's medical and quality of life needs that have been largely ignored by the pharmaceutical industry.
"It's not just about sex," FemmePharma President and CEO Gerianne DiPiano said. "For women in menopause, pain and discomfort don't begin and end with intercourse. It's a daily problem that needs to be addressed through daily self-care. Otherwise, a woman's quality of life will continue to suffer."
Satisfaite™ is an intravaginal personal lubricant intended to moisturize, lubricate and supplement the body's natural lubrication which the women's healthcare company developed over the past decade based on its proprietary technologies and pharmaceutical industry expertise. The physical and chemical properties of the delivery system provide a sophisticated, easy to use, and esthetically elegant alternative to existing lubricants and moisturizers. The 510(k) clearance indicates that Satisfaite™ meets the highest standards for safety and effectiveness for a Class 2 medical device.
"There has never been adequate research into products to improve the quality of life for women," said DiPiano. "Our goal is to change that and provide women with new and better options for a life they deserve."
An estimated 64 million women in the US are in natural menopause, according to demographic data. Millions more experience chemically-induced menopause following treatment for breast cancer, autoimmune diseases such as Sjogren's syndrome, and severe endometriosis. Due to declining estrogen levels, roughly half of menopausal women suffer vulvar and vaginal symptoms including vaginal dryness, burning, urinary urgency and frequency, irritation and pain during intercourse. Left untreated, these symptoms of menopause can negatively impact a woman's overall health, emotional well-being and quality of life.
Satisfaite™ delivers an optimized dose of FemmePharma's proprietary, pharmaceutical-grade vaginal lubricant and moisturizer to alleviate pain and discomfort and improve the health of the vaginal mucosa. In addition to causing detrimental menopausal symptoms, a breakdown in the vaginal mucosa is a known risk factor for contraction of HIV and other sexually-transmitted diseases.
Satisfaite™ can be used alone or in conjunction with FemmePharma's complementary vulvar moisturizers – Satisfem™ Gel and Satisfem™ Bud -- as part of a menopausal woman's daily self-care regimen. Satisfem™ Gel is not made with hormones and has a hydrating formula that reduces vulvar itching, burning and irritation. The Satisfem™ Bud contains a hydrating formula in a single-use swab applicator that fits discreetly into a pocket or purse.
Backed by 20 years of scientific research, and designed by women for women, FemmePharma's pharmaceutical-grade, over-the-counter products offer women a high-quality, effective alternative to existing products which can be messy, leaky, inconvenient and challenging to use.
Satisfaite™ will be available for commercial sale, exclusively on-line, in 1Q 2020. Satisfem™ Gel and Satisfem™ Bud are available online at https://femmepharma.com/.
FemmePharma is the first and only company dedicated to women's menopausal health. Our mission is to bring innovative products to market that safely and effectively alleviate the symptoms of menopause.
Our pharmaceutical-grade research and development process, strict product manufacturing standards, and commitment to great customer service provide women with the symptomatic relief and peace of mind that they have been seeking. For more information visit femmepharma.com or call (833) FEM-PHRM (833-336-7476).
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