Futura Medical has announced Phase 3 data on its topical erectile dysfunction treatment MED3000, clearing the path for an FDA filing that could make the therapy an over-the-counter treatment option for erectile dysfunction.
Phosphodiesterase type 5 inhibitors (PDE5is) such as Viagra (sildenafil) and Cialis (tadalafil) and generic equivalents currently dominate the erectile dysfunction market.
Sildenafil and tadalafil are among the most widely prescribed drugs on the market.
“Whilst PDE5is are effective treatments, they have certain drawbacks,” said Ken James, executive director and head of R&D of Surrey, UK–based Futura Medical.
For one thing, PDE5i side effects can include headache, flushing, nasal congestion and back pain. In addition, FDA has repeatedly warned about the potential of synergistic hypotensive effects resulting from combining PDE5is with nitrates.