November 18, 2009 / 11:31 AM / 10 years ago

Vivus says erectile dysfunction trial meets goals

* 57 pct of 100mg/200mg avanafil patients have intercourse

* Intercourse achieved in 30 minutes or less

* Two other third-stage trials underway

* FDA filing late 2010 or early 2011

* Shares up 7.3 percent in after hours trade.

By Deena Beasley

LOS ANGELES, Nov 18 (Reuters) - The erectile dysfunction drug being developed by Vivus Inc (VVUS.O) met the goals of a Phase 3 trial, and was shown to be effective in 30 minutes or less, the company said on Wednesday.

The 646-patient late-stage trial found that about three-quarters of patients taking either a 100 mg or a 200 mg dose of the drug, avanafil, had erections sufficient for intercourse. Fifty-seven percent experienced “successful intercourse,” compared with 27 percent of placebo patients.

Avanafil, works by inhibiting the PDE5 enzyme, the same target as Pfizer Inc’s (PFE.N) Viagra and Eli Lilly and Co’s (LLY.N) Cialis. But the company said it is designed to act faster than the two other drugs.

Sales of current erectile dysfunction therapies total more than $3.5 billion a year.

Shares in Vivus were up more than 7.3 percent in after hours trade on Tuesday on the Nasdaq. During the regular trading session, before the company announced it would hold a conference call on Wednesday about the avanafil results, shares were up more than 9 percent to close at $8.57.

Vivus spokeswoman Sheryl Seapy said the stock activity may have been due to the re-emergence of a takeover rumor.


“For patients in all market research studies, their No. 1 desire is for an on-demand therapy,” said Vivus Chief Executive Leland Wilson.

He said Viagra is labeled for a 60-minute time to maximum plasma levels, and Cialis’ time-to-onset is two hours.

“Ours is 35 minutes. Patients want to have sex sooner rather than later,” Wilson said.

Vivus said the trial met all of its primary goals across the three doses studied, showing statistically significant improvement in erectile function, as well as a favorable side-effect and safety profile.

It also said there no serious side effects. Some patients reported common side effects seen with other erectile dysfunction drugs, such as flushing and headaches.

He also said patients in the trial reported that avanafil’s duration lasted beyond six hours.

Wilson said Vivus is currently conducting two other late-stage trials of avanafil, one in diabetics and another in men who have undergone radical prostatectomy. The company is also conducting an open label safety study.

Those results are expected next year and the company plans to file for regulatory approval of the drug late next year or early 2011, he said.

The CEO said Vivus has no plans to partner the drug until the full Phase 3 data set is complete.

Vivus, based in Mountain View, California, plans to file for U.S. regulatory approval of its experimental weight loss drug, Qnexa, before the end of this year. (Reporting by Deena Beasley; editing by Leslie Gevirtz)

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