Avanafil long-term phase 3 trial in erectile dysfunction meets primary endpoints

October 07, 2017

"The avanafil data from the open label, long-term safety study confirm the safety and efficacy results previously observed in the two placebo-controlled trials," commented Dr. Belkoff.  "The safety profile demonstrated during the year-long study and successful intercourse attempts within 15 minutes of dosing suggest avanafil, if approved, may be an attractive treatment option for men with ED."

Highlights of the TA-314 study include:

Eighty percent (80%) of sexual attempts among patients on avanafil resulted in erections sufficient for intercourse (SEP 2)Erectile function as measured by IIEF scores improved over 80% from baselineSuccessful intercourse was achieved as early as 15 minutesAvanafil was well tolerated as evidenced by a low rate of discontinuations due to adverse events (<3%)The most common side effects reported were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%)There were no drug-related serious adverse events reported in the study