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Ampio Pharmaceuticals, Inc. Releases Results From Phase III Clinical Trial of Zertane™ for the Treatment of Premature Ejaculation (PE), the Most Prevalent Form of Male Sexual Dysfunction
Date:6/27/2011

baseline (data from meta analysis by McMahon on 5 trials using dapoxetine(3)).
  • Zertane™ at the higher dose increased median IELT 2.49 fold over baseline. The mean increase was 4.26 fold over baseline. Geometric mean increased 2.4 fold over baseline. For comparison purposes dapoxetine (Priligy®) at the higher dose increased geometric mean IELT 2.3 fold over baseline.
  • The results were even more pronounced in the men with median IELT of 1 minute or less. Zertane™ at the lower dose increased IELT 2.44 fold and 3.33 fold at the higher dose.  The mean IELT increased by 5.2 fold for the lower dose and 6.0 fold for the higher dose of Zertane™.
  • The mean change for all four aspects of the PEP (normal distribution) was significantly higher in both Zertane™ treatment groups compared to placebo.
  • Independent of dosage, a significantly higher proportion of men treated with Zertane™ met the criteria of clinical benefit compared to placebo.  Similar results were observed in the subset of patients whose baseline median IELT was less than 1 minute.
  • Also analyzed was the female partners' sexual satisfaction. For Zertane™ groups, compared to placebo, a significantly higher proportion of females achieved a 1 category or greater improvement in satisfaction with sexual intercourse, in their partner's control over ejaculation and in distress related to partner's speed of ejaculation.
  • Safety of the two doses was monitored by recording adverse events, concomitant drug use and vital signs at each visit. All treatment emergent adverse events (TEAE's) were recorded by system organ class, severity and relation to study medication. The incidence of TEAE's was 4.84% and the overall adverse event rate was 11.8%. The most common adverse event was erectile dysfunction (1%, n=6). All other adverse events had incidence of less than 1%. No serious adverse events were observed. No statistical difference
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  • SOURCE Ampio Pharmaceuticals, Inc.
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