Cellegy Pharmaceuticals Inc announced results of a study regarding the use of topical nitroglycerin (NTG) for the treatment of women with vulvodynia. The paper published was authored by Dr. Kathleen Walsh and her co-investigators at the University of California, Los Angeles Medical Center.
Vulvodynia is categorized by symptoms of vulvar pain, regardless of etiology. This pain is usually cyclic, occurring just before or during menses and is exacerbated by sexual intercourse. It is estimated that vulvodynia affects as many as 15% of women in the general gynecologic population. Currently, there are no approved medical treatments indicated for the treatment of vulvodynia.
This open label study included 34 women diagnosed with vulvodynia. Topical treatment with NTG was initiated in the clinic and was continued at home for four to six weeks. Patients were instructed to use topical nitroglycerin five to ten minutes before sexual relations and, as part of the study, patients completed pre and post treatment questionnaires.
An improvement in pain was reported by 91.5% of patients (31/34). Significant decreases in pain intensity (P<.0001) and frequency of overall pain (P<.006) were also reported. The most common side effect was headache.
Dr. Jennifer Berman, one of the study's co-investigators commented, "Topical NTG is safe and effective in providing pain relief of vulvodynia. This will be a significant advance in the medical treatment of a painful condition that affects millions of women."
Cellegy has a number of issued and pending patents on the use of nitric oxide donors for the treatment of female sexual dysfunction, and intends to develop a topical NTG product for vulvodynia.