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MED2005, a new topical treatment for erection problems, took an important step forward in early 2018 with the publication of results from its Phase II trial.
That testing showed that the medication delivered a rapid onset of action while maintaining a favorable safety profile.
The medication’s developer, United Kingdom-based Futura Medical, announced that it hoped to begin two Phase III trials sometime in 2018.
These additional trials will assess the drug’s efficacy and safety at varying dose levels in a larger study population and are a necessary step before seeking Food and Drug Administration approval for a new medication.
MED2005’s forward momentum comes only a short time after the FDA rejected for the second time another topical ED drug called Vitaros.
Apricus Biosciences, which developed Vitaros, is considering how, if at all, to move forward with Vitaros based on FDA’s safety concerns about the formulation of the drug.
What Phase II Trial Entailed
MED2005’s Phase II trial involved 230 men diagnosed with varying degrees of erectile dysfunction and was carried out at one site in the United Kingdom and three in Poland. The double-blind, placebo-controlled study delivered a rapid onset of action — 10 minutes or less in 70 percent of those using the active drug — with no adverse side effects of any consequence.
Improvements in erectile function were most noticeable in men whose erection problems were classified as mild to moderate. Higher doses will be tested during Phase III trials to see if they help men with more severe erection problems. Results of the Phase II trial were published in the February 2018 issue of “The Journal of Sexual Medicine.”
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