Ampio Pharmaceuticals (AMPE: Quote) Monday said the FDA has accepted its evaluation tool, the Patient Outcome for Premature Ejaculation or POPE questionnaire, a modification of the Premature Ejaculation Profile or PEP questionnaire for a pivotal trial of Zertane, intended for the treatment of Premature Ejaculation or PE. The acceptance allows Ampio, or a pharmaceutical partner to file an investigational new drug or IND application in the USA for a pivotal trial of Zertane with POPE as a co-primary end-point along with Intravaginal Ejaculatory Latency Time.
The company noted that PEP was used in the two successful Phase 3 clinical trials of Zertane, completed in Europe.
POPE was tested in a clinical trial to assure the FDA’s SEALD division that the verbal responses of the patients to physician questions following their treatment would accurately reflect their clinical response to the drug, said the company.
Commenting on the development, Michael Macaluso, Ampio’s CEO, said, “The drug has already been manufactured and ready for the trial. The CMC created for Zertane is also being submitted to the TGA, the Australian FDA, as the last piece for registration of Zertane in Australia.”
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by RTT Staff Writer
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