VIVUS Inc. (VVUS) announced that results from the REVIVE study were published in The Journal of Sexual Medicine. REVIVE (TA-301) was a randomized, placebo-controlled, phase 3 study evaluating the safety and efficacy of avanafil, an investigational drug currently under review by the Food and Drug Administration for the treatment of erectile dysfunction or ED.
Following 12 weeks of treatment, without restrictions on food or alcohol, all three doses of avanafil (50mg, 100mg and 200mg) were significantly superior to placebo for all primary endpoints (p
The company note that a secondary analysis using Sexual Encounter Profile, question 3 (SEP 3) to evaluate the number of successful intercourse attempts at various time points post-dosing revealed that avanafil was associated with a significant treatment response as early as 15 minutes and beyond 6 hours after dosing.
Nearly 80% of all sexual attempts among patients in the 200mg dose group of avanafil had erections sufficient for intercourse. 72% of study participants had tried at least one other ED treatment.
The most common side effects were headache, flushing, nasal congestion and back pain and no drug-related serious adverse events reported.
The completion rate in REVIVE was 85.1% and discontinuations due to adverse events were 1.9%, 3.1%, 2.5% and 3.1% for the 50mg, 100mg, 200mg and placebo groups, respectively.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.