Ampio Pharmaceuticals Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities (NMEs), has submitted to the US FDA a pre IND package on Zertane, its on-demand premature ejaculation drug, for a meeting and discussion on the approval path under the 505(b) 2 regulation/registration requirement in the US.
Michael Macaluso, Ampio's CEO, noted that “Zertane successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open label study of 101 patients demonstrated no abuse potential or dependency.”
Macaluso continued, “Ampio is currently in discussions with potential partners for the distribution of Zertane and Zertane in combination with an erectile dysfunction drug. These negotiations require clarity about the appropriate regulatory path to commercialization in the United States and so we are seeking the FDA's guidance.”
Zertane is a repurposed oral drug to treat 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 for other medical indications. 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 on a daily basis.
Published in the September 2011 journal of European Urology: “A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Orally Disintegrating Tablet for the Treatment of Premature Ejaculation Less than 2 Minutes” authored by Dr David Bar-Or, MD, the Chief Scientific officer and his colleagues at Ampio Pharmaceuticals Inc, details the successful efficacy and safety outcomes of the use of Zertane in double blinded, placebo controlled phase III trials involving 604 intent to treat patients in 11 countries and 62 sites in Europe. Premature ejaculation is a widely observed male sexual dysfunction with an estimated prevalence between 2% and 23% of the world male population.
Studies have shown that PE is associated with poor satisfaction with sexual intercourse and high levels of ejaculation-related personal distress and interpersonal difficulty. The study conclude that on demand Zertane provides a new option for managing mild to severe PE and that very favorable efficacy and safety profiles exist. The median IELT (intravaginal ejaculatory latency time) of Zertane increased by 1.2 minutes (2.4 fold increase) compared to placebo (p<0.001). All four measures of the PEP (Premature Ejaculation Profile, a validated questionnaire) scores improved significantly compared to placebo (p<0.05) in men and a large percentage of women partners who had poor or very poor satisfaction with sexual intercourse, partner's control over ejaculation and speed of ejaculation improved significantly with Zertane in at least one category or greater with satisfaction with sexual intercourse (p=0.01), their partner control over ejaculation (p<0.001) and distress over partner's speed of ejaculation (p=0.02).
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction.