Ampio

Zertane™ for Premature Ejaculation (PE)

Zertane™ is an oral drug 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 multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane™ from other treatments for premature ejaculation. Zertane™ is taken as needed before sexual activity and is not required to be taken on a daily basis.

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 excellent safety in initial trials for premature ejaculation. No serious adverse side effects were caused by Zertane™ and only very rarely did any non-serious side effect cause men to stop taking the drug.

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 a numbing anesthetic drug spray for the penis have been approved in some other countries. Both of these drug treatments are reported to have adverse effects that may limit their use.

Clinical data comparisons indicate that Zertane™ surpasses the efficacy reported for dapoxetine (Priligy®), an SSRI antidepressant-type drug and the only oral drug approved anywhere for the treatment of premature ejaculation. The established Zertane™ drug dose for delaying ejaculation has a decades-long safety record that is superior to SSRI antidepressant-type drugs. SSRI antidepressant-type drugs can have serious adverse medical effects in addition to frustrating sexual side effects.

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