Vivus reports advances among product candidates, expects Qnexa phase 3 trials to start in 2007

By Jennifer Lanning Drey

Eugene, Ore., May 18 - Vivus, Inc. reported what it described as promising advances among its pipeline of sexual health-related product candidates, as well as its obesity treatment candidate, Qnexa, during its analyst day presentation held on Thursday.

Vivus expects to begin phase 3 clinical trials of Qnexa, a proprietary pharmaceutical treatment for weight loss that contains low doses of the active ingredients phentermine and topiramate, by mid-2007, said Wesley Day, vice president of clinical development for Vivus, during the conference.

Based on its understanding of phase 3 clinical requirements, the company expects to submit a New Drug Application for Qnexa in 2009 and receive approval for it about a year later, said Day.

"I think Qnexa truly is a breakthrough. It's a breakthrough for safety and it's a breakthrough for efficacy. Our phase 3 program will tell us a lot more in a larger population for a longer period of time," he said during his presentation.

Upon completion of a phase 2, 24-week double-blind, placebo-controlled clinical trial comparing Qnexa, a placebo and a phentermine and topiramate combination, Vivus reported that the treatment group demonstrated 10% or more total body weight loss.

Mean weight loss on an intent-to-treat basis in the Qnexa group was 25.1 pounds compared to 4.8 pounds in the placebo group, according to a company news release.

"Patients lost twice the weight in half the time compared to published data for other available therapies," said Day in his presentation on Thursday.

Vivus must complete two three-month animal studies and finalize the formulation, which will be a once-a-day treatment to optimize the delivery of the drug, before beginning phase 3 clinical trials.

Defines testosterone spray studies

Vivus also reported during Thursday's conference that it has had three meetings with the Food and Drug Administration to define the safety studies that will be necessary to bring its Testosterone Metered Dose Transdermal Spray (MDTS), used to treat hypoactive sexual desire disorder, to the market.

The FDA has said in the past that it will require long-term studies before approving testosterone treatments like Testosterone MDTS, said Peter Tam, senior vice president of product and corporate development for Vivus.

In February 2005, Vivus announced that phase 2 clinical trials on Testosterone MDTS had shown a statistically significant improvement in the number of satisfying sexual events in pre-menopausal patients with hypoactive sexual desire disorder.

Vivus has been successful at defining the critical factors such as the FDA's requirements of how big its next study needs to be, its endpoints in terms of safety and how to analyze the endpoints, said Tam on Thursday.

"We believe that the size and scope of the study from a cost standpoint is certainly do-able," he said.

Vivus also highlighted results from the pivotal phase 3 clinical trial of Evamist, a once-daily transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women, during Thursday's presentation.

As previously reported, the trial results showed that the most effective Evamist dose significantly decreased the number of hot flashes by 78%, to 2.3 hot flashes after treatment from 10.7 hot flashes per day at baseline.

Alista, Vivus' topical formulation of alprostadil for the treatment of female sexual arousal disorder, and its avanafil treatment for erectile dysfunction also both showed positive results in phase 2 clinical trials, according to presenters at Vivus' Analyst Day.

Vivus is a Mountain View, Calif., company working on products to restore sexual function for women and men

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