VIVUS Avanafil phase 3 trial on erectile dysfunction meets primary endpoints

October 16, 2017

Highlights of the TA-303 study include:

Treatment with both doses of avanafil (100 mg and 200 mg) was associated with significant improvements in each of the co-primary endpoints, SEP2, SEP3 and IIEF-EF in comparison with placebo (p <0.001)Patients treated with 100 mg and 200 mg of avanafil improved their ability to have successful intercourse (SEP3) four- and five-fold, respectively, from the start of treatmentTreatment with avanafil improved erectile function in a dose-dependent manner with significant increases in the IIEF scores from the beginning of treatment through the end of treatment.  Erectile function scores increased 38% and 55% for patients on the 100 mg and 200 mg doses, respectively, as compared to the placebo group with an increase of 1%The most commonly reported side effects in patients taking avanafil included headache, flushing, and nasopharyngitisThere were no serious adverse events or deaths reported in the study