Ampio Pharmaceuticals has completed an extension study for its premature ejaculation drug, Zertane, which began on the back of their successful phase III trials. The aim of the study was to evaluate the safety and efficacy of Zertane in the treating of premature ejaculation.
101 participants were given a higher dose of the drug and they received a follow-up every 3 weeks on four occasions. Only 6 participants experienced adverse effects and this came in the form of either anxiety or erectile dysfunction.
There were no serious adverse events reported during the Zertane phase III trial or this extension study and the number of such events reported were few. Only one event was treatment related. It was revealed that accompanied by a longer follow-up, even the higher dose of this drug is safe.
Zertane is likely to get the approval it is seeking considering that its active ingredient, Tramadol hydrochloride, is already on the market and the results of this extension study have been altogether positive. It is believed that approximately 23% of men suffer from premature ejaculation so it is surprising that there is still only one treatment on the market, Priligy. We will keep an eye out for this treatment but if the manufacturer gets the pricing right, this has the potential to be a blockbuster drug.