Zertane™ for Premature Ejaculation (PE)
Zertane™ is an oral drug candidate in successful late stage development as a proprietary treatment for premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient in Zertane™ has one or multiple mechanisms of actions that can delay ejaculation. This drug candidate also has a favorable safety record established during 30 years of human use. These unique pharmaceutical qualities, favorable human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane™ from other treatments for premature ejaculation. We intend that our labeling for Zertane™, if regulatory approval is obtained, will suggest “as required” dosing before sexual intercourse and not to exceed one tablet per day.
Initial randomized, controlled clinical trials (phase II) demonstrated that Zertane™ is an effective treatment with few adverse side effects for men with premature ejaculation. Men taking Zertane™ had significantly delayed intravaginal latency times (IELT), increased control of ejaculation, improved sexual satisfaction and less interpersonal distress compared to placebo. Zertane™ also demonstrated favorable safety profile in initial trials for premature ejaculation. No serious adverse side effects were caused by Zertane™.
Ampio completed the analysis of Phase III clinical trials conducted in Europe with Zertane™ as a fast dissolving oral tablet for premature ejaculation. Ampio believes Zertane™ represents a substantial global market opportunity and, to realize this opportunity and enhance Ampio’s global presence, has formed an international commercialization team to support the progression of Zertane™ through European and other international regulatory processes as well as outsourcing the manufacturing, supply and distribution of Zertane™.
No drug has yet been approved in the U.S. for the treatment of premature ejaculation, although an SSRI antidepressant drug and another prescription drug have been approved in some other countries. Both of these drug treatments are reported to have adverse effects that may limit their use.