Development for Zertane-ED, Combo Drug for Premature Ejaculation and Erectile Dysfunction, Continues
Ampio Pharmaceuticals, Inc. announced on July 2 that it is proceeding with the development plan for Zertane-ED, a combination product to treat both premature ejaculation and erectile dysfunction. A positive pre-IND meeting with the FDA in June 2012 gave the company clear guidance for the two concurrent pivotal trials necessary for approval of Zertane to treat premature ejaculation in the U.S.
As a first step in the clinical evaluation of Zertane-ED, Ampio entered into an agreement with Syngene, located in Bangalore, India, to begin manufacturing the combination product for a phase III study of these comorbid conditions in South Korea. The data generated by this trial will be used to support an FDA submission.
Zertane is a repurposed oral drug to treat premature ejaculation, a condition that has a major effect on the quality of life for men and their sexual partners. The active ingredient in Zertane has multiple mechanisms of actions that can delay ejaculation. Zertane is taken as needed before sexual activity and is not required on a daily basis.
No therapies are currently available for men who experience both premature ejaculation and erectile dysfunction.
Read the full news story in the Sacramento Bee.