New erectile dysfunction medication awaiting FDA approval
Vivus Inc. have announced that they have submitted a “New Drug Application” (NDA) to the US Food and Drug Administration (FDA), for a new medication to be entered into the lucrative $4 billion erectile dysfunction market. The new drug, named “Avanafil”, may take several months for its FDA approval to be confirmed and will be thrust into an increasingly competitive market that already includes Viagra, Cialis, and the newly introduced Levitra Orodispersible tablets. Clinical trials with Avanafil have taken place involving over 1,350 subjects, with 50mg, 100mg, and 200mg dosage strengths being analysed. The NDA submitted by Vivus is backed up by including data from Phase 3 trials and these trials were said to have proved the drug’s safety and efficacy. Results showed that patients who had taken the 200mg dose, had achieved an erection sufficient for penetration in 77% and 63% of the trials, in comparison to just 54% and 42% in patients dosed placebo. In addition, many patients were able to have successful intercourse in a mere 15 minutes of taking Avanafil. With the patent for Viagra due to expire in 2012, the market for impotence medication will become very interesting in the following year and we may yet see many more new and exciting products being introduced.