FemmePharma Gets USFDA 510(K) Clearance for Satisfaite

satisfaite personal lubricant vaginal moisturizer

FOR IMMEDIATE RELEASE

CONTACTS:
Lauren Perez, FemmePharma, 610-995-0801, [email protected]                                                                                 Staci Vernick, SL Vernick Communications, 610-812-6092, [email protected]

COMING SOON: A MENOPAUSAL SOLUTION THAT’S NOT ALL ABOUT SEX

(PHILADELPHIA – Jan. 7, 2020) — 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 SatisfaiteTM delivery system for the relief of vaginal symptoms of menopause affecting more than one in three women in the U.S. alone.

With SatisfaiteTM, 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.”

SatisfaiteTM 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 SatisfaiteTM 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 U.S. 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.

SatisfaiteTM 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.

SatisfaiteTM can be used alone or in conjunction with FemmePharma’s complementary vulvar moisturizers — SatisfemTM gel and SatisfemTM Bud — as part of a menopausal woman’s daily self-care regimen. SatisfemTM gel is not made with hormones and has a hydrating formula that reduces vulvar itching, burning, and irritation. The SatisfaiteTM 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.

SatisfaiteTM will be available for commercial sale, exclusively online, in 1Q 2020. SatisfemTM gel and SatisfemTM Bud are available online at femmepharma.com.

About FemmePharma

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).

About the author
FemmePharma started as a pharmaceutical research and development company more than 20 years ago. We’ve been reinventing women’s healthcare ever since.

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