FemmePharma Granted US FDA 510(k) Clearance for Satisfaite™
PHILADELPHIA--(BUSINESS WIRE)--Dec 17, 2019--
FemmePharma today announced it 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 TM delivery system for the relief of vaginal symptoms of menopause affecting more than one in three women in the US alone.
Satisfaite TM is an intravaginal personal lubricant intended to moisturize and lubricate and supplement the body’s natural lubrication which FemmePharma developed based on its proprietary technologies and know-how. 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 TM meets the highest standards for safety and effectiveness for a Class 2 medical device.
“We are excited that at FemmePharma was able to meet the exacting standards set by the US FDA, and we are committed to delivering products that are differentiated, not only by adherence to exacting standards but also geared to providing a product that meets the needs of women and that they feel they can use with confidence,” said FemmePharma President and CEO Gerianne DiPiano.
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, 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 TM delivers an optimized dose of FemmePharma’s proprietary, pharmaceutical-grade vaginal lubricant and moisturizer to alleviate 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 TM can be used alone or in conjunction with FemmePharma’s complementary vulvar moisturizers – Satisfem TM Gel and Satisfem TM Bud -- as part of a menopausal woman’s daily self-care regimen. Satisfem TM Gel is not made with hormones and has a hydrating formula that reduces vulvar itching, burning and irritation. The Satisfem TM 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 and 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 TM will be available for commercial sale, exclusively on-line, in 1Q 2020. For more information, visit 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 designed to 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).
View source version on businesswire.com:https://www.businesswire.com/news/home/20191217005131/en/
CONTACT: Lauren Perez
SL Vernick Communications
KEYWORD: PENNSYLVANIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: WOMEN FDA BIOTECHNOLOGY OTHER HEALTH HEALTH CONSUMER PHARMACEUTICAL OTHER SCIENCE SCIENCE
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PUB: 12/17/2019 09:37 AM/DISC: 12/17/2019 09:37 AM