Futura Medical has reported phase 3 data on its topical erectile dysfunction treatment MED3000, teeing it up to file for FDA approval of the therapy as an over-the-counter medicine by the end of the month.
Featuring Futura’s DermaSys drug delivery technology, MED3000 is designed to stimulate nerve sensors when applied to the head of the penis, leading to smooth muscle relaxation, tumescence and erection. In the phase 3 study, investigators randomized 96 men clinically diagnosed with mild, moderate or severe erectile dysfunction to use MED3000 or oral tadalafil, the active ingredient in Eli Lilly’s Cialis.
After 24 weeks, Futura saw a statistically significant improvement from baseline in erectile dysfunction, as measured using the International Index of Erectile Function (IIEF-EF) questionnaire, causing the trial to hit one of its co-primary endpoints.
The other co-primary endpoint showed that participants experienced an average change from baseline on the IIEF-EF score of 5.73 units, exceeding the 4-unit difference on which Futura said it agreed with the FDA. MED3000 outperformed tadalafil in terms of speed of onset of action, leading Futura to talk up the prospect of it making a claim such as “helps you get an erection within 10 minutes.”
Futura reported tolerability advantages of MED3000 over tadalafil, such as the reduced frequency of headaches, but in other regards the oral therapy performed better. “Overall tadalafil showed a greater improvement in erectile function than MED3000,” Futura said in a statement.
Even so, the company thinks it has the data to support approval, leading it to aim to file its dossier by the end of the month. If Futura hits its target, the FDA could grant marketing authorization to MED3000 in the first quarter of next year.