Vivus has presented data on its already-approved but not-yet-marketed erectile dysfunction drug Stendra which shows that the treatment is effective for sexual activity within 15 minutes.
Stendra (avanafil) was given the green light by the US Food and Drug Administration over a year ago, but there has been no launch yet as Vivus has been seeking a partner. The latest data should be attractive to potential suitors and could help Stendra take on other phosphodiesterase type 5 (PDE5) inhibitors, notably Pfizer’s Viagra (sildenafil) but also Eli Lilly’s Cialis (tadalafil) and Bayer’s Levitra (vardenafil).
In the study, Stendra patients achieved statistically significant improvement over placebo, in the attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes for the 200mg dose and 12 minutes for the 100mg dose after being taken. The trial randomised 440 patients (average age 58) and most of them had previously used other ED therapy. The most common drug-related side effects were headache and nasal congestion.
Vivus president Peter Tam noted that the recommendations for use of current PDE5 inhibitors instruct patients to wait one to two hours prior to sex or to take the medication daily. He added that having a shorter waiting time in the label, “if approved, would provide Stendra with a differentiated profile that is desired by many patients and prescribers”. It is currently prescribed to be taken 30 minutes before sex.
The firm’s head of clinical development, Wesley Day, said an amendment to the FDA approval and the pending European Medicines Agency application (where the drug will be called Spedra) has been made to include the results of this study. If approved, the drug “will have the unique advantage of being the only PDE5 inhibitor to be able to make this claim”.
Stendra was licensed from Japan’s Mitsubishi Tanabe Pharma Corp and Vivus noted that it is in talks with potential partners for the USA and the rest of the world. Bagging a deal is hugely important for Vivus, not only for Stendra but also more importantly its obesity drug Qsymia (phentermine/topiramate).
