Cellegy Pharmaceuticals Inc announced that the United States Patent and Trademark Office (USPTO) has issued patent number 6,610,652 entitled "Microdose Therapy."
This patent delineates methods of treating urogenital disorders in females, using a nitric oxide (NO) donor or a phosphodiesterase (PDE) inhibitor. Such urogenital disorders include pain during intercourse (dyspareunia), decreased vaginal lubrication, and decreased vaginal engorgement. Commonly known NO donor compounds include nitroglycerin and sodium nitroprusside; PDE inhibitors include sildenafil (Viagra, Pfizer), vardenafil (Levitra, Bayer) and tadalafil (Cialis, Lilly/ICOS). This patent increases the Company's intellectual property portfolio to 5 issued United States patents and over 20 pending United States and foreign patent applications for the treatment of urogenital disorders and female sexual dysfunctions using NO donors and related compounds.
Dyspareunia is characterized by difficult or painful sexual intercourse afflicting approximately 5 million women in the United States. Treating dyspareunia with a nitric oxide donor could potentially provide significant benefits to patients who are poorly served by currently available treatments, such as lubricants. The utility of nitroglycerin ointment in the treatment of vaginal pain was previously demonstrated in a pilot study conducted by Dr. Jennifer Berman at UCLA Medical Center.
"Cellegy is pleased to add this issued patent to the Company's expanding intellectual property portfolio for the treatment of urogenital disorders and female sexual dysfunctions using nitric oxide donor compounds," said David A. Karlin, Cellegy's Vice President, Clinical Development. "We plan to initiate a confirmatory dose ranging clinical study using nitroglycerin for the treatment of dyspareunia before the end of this year."