FemmePharma has been given a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Satisfaite, a delivery system for intravaginal lubricants that relieve the vaginal dryness associated with menopause, a symptom that affects women with Sjögren’s syndrome more than others.
The clearance indicates that Satisfaite meets the highest standards for safety and effectiveness for a class 2 medical device, or those that otherwise pose moderate to high risk to patients.
“We are excited that FemmePharma was able to meet the exacting standards set by the U.S. 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,” Gerona DiPiano, FemmePharma president and CEO, said in a press release.
About 64 million women in the US are in natural menopause, and millions more experience chemically induced menopause as a consequence of treatments for diseases like breast cancer, Sjögren’s syndrome, and endometriosis.
Around half experience vaginal atrophy as a consequence of the lower blood estrogen levels menopause brings. Symptoms include vaginal dryness, burning, and itching, as well as pain during intercourse.
Sjögren’s is an autoimmune condition where the immune system attacks and damages secreting glands, leading to symptoms of dryness, most commonly in the eyes and mouth. But glands producing natural vaginal lubricants can also be affected, causing vaginal dryness.
Women with Sjögren’s syndrome are reported to be two-to-three times more likely to experience vaginal dryness than women of the same age without this condition. They also tend to have more severe manifestations.
Treatments for vaginal atrophy include vaginal moisturizers, water-soluble lubricants, and vaginal creams containing estrogen.
Satisfaite consists of a bud (or swab) containing a proprietary lubricant that comes with a single-use vaginal applicator. The pharmaceutical-grade vaginal lubricant does not contain hormones, and has a hydrating formula specially designed to supplement natural lubrication.
The system delivers an optimized dose of the lubricant, FemmePharma reports, which helps to alleviate the discomfort caused by vaginal dryness — including burning, itching, and irritation — and improve the health of the vaginal mucosa.
Satisfaite can be used alone or in combination with external lubricants and moisturizers as part of a woman’s daily care regime.
FemmePharma states that the delivery system is easy to use, is more esthetic and comfortable than existing lubricants and moisturizers, and that the applicator fits easily into a pocket or purse. Satisfaite will be available for sale online at the company’s website starting in early the 2020.