VIVUS Tapping ED Hurdles (VVUS, PFE, LLY)
VIVUS Inc. (NASDAQ: VVUS) may soon have a new erectile dysfunction drug on the market if the test results lead to an FDA approval. Shares are trading higher this morning after it announced positive results in a phase 3 pivotal study evaluating the safety and efficacy of avanafil for the treatment of erectile dysfunction.
If everything is as solid as it sounds, it looks like Pfizer (NYSE: PFE) via Viagra and Eli Lilly & Co. (NYSE: LLY) via Cialis may have a new competitor.
The 646 patient study met the safety and efficacy enpoints of avanafil, with what may be some lower side effects than traditional ED drugs. The endpoints were also met across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score.
Nearly 80% of sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse. Full efficacy was reported by patients in 30 minutes or less, which is better than current ED drugs. Full efficacy was maintained for all doses across multiple time points beyond six hours.
The company also noted that all FDA-defined primary endpoints were met across all three doses of avanafil, and it was well tolerated as demonstrated by a high retention rate (85%). More importantly, there were no drug-related serious adverse events in the study and patients had low reports of common PDE5i side effects.
VIVUS shares are up 13% at $9.72 in pre-market trading and the 52-week trading range is $2.72 to $12.88.
JON C. OGG