|Vivus and SANUWAVE Health drop on bad news|
|By Staff and Wire Reports|
|Thursday, 22 December 2011 10:13|
The Mountain View, Calif., company said that women who took topiramate, one of the two main ingredients in its drug Qnexa, during the first trimester of pregnancy were about twice as likely to give birth to a child with cleft lip or cleft palate, compared with women who had taken the drug in the past but not while pregnant.
The data is based on an analysis of more than 15,000 past medical claims and was not taken from a clinical trial of Qnexa. Vivus had agreed to conduct the analysis after the Food and Drug Administration refused to approve Qnexa last year. Vivus said it is working to confirm the medical claims and expects to complete that process in next year's third quarter.
Vivus said in October it had resubmitted its FDA application for Qnexa, which was once touted by many experts as the most promising weight-loss drug in more than a decade. The development has created some doubts, said Jefferies analyst Thomas Wei.
"These data leave us more cautious for a broad approval covering women of child bearing age," he wrote. Brean, Murray, Carret & Co. analyst Jonathan Aschoff said the results do not support the drug's approval.
Vivus shares fell $1.62 to $8.78 before the market opened.
"We have had an interactive and timely review with the FDA throughout the PMA process and believe our communications have been productive and further the common understanding between SANUWAVE and the FDA regarding our dermaPACE PMA application. We believe our submission provided clinical data which demonstrates that dermaPACE positively impacts wound healing in these clinically challenging diabetic foot ulcers,” noted Christopher M. Cashman, President and CEO of SANUWAVE. “We will continue to work toward our goal of a positive approval decision from the FDA so we can bring this novel, promising treatment to the millions of patients who suffer from these debilitating, recalcitrant wounds."
As previously reported, the primary efficacy endpoint prospectively defined in the dermaPACE pivotal study protocol was the incidence of complete wound closure at 12 weeks following initial application of dermaPACE (active or sham) in ulcers four weeks or older in duration. In the study, dermaPACE increased the proportion of diabetic foot ulcers that closed within 12 weeks by 36% over Sham-control, but this difference was not statistically significant (p=0.363). There were 22 out of 107 (21%) dermaPACE subjects who achieved complete wound closure at 12 weeks compared with 15 out of 99 (15%) Sham-control subjects.
In addition to the originally proposed 12-week efficacy analysis, and after discussions with the FDA at the pre-PMA meeting, SANUWAVE conducted a series of secondary analyses of complete wound closure at 12 weeks and at each subsequent study visit out to 24 weeks. The endpoint of complete wound closure reached statistical significance at 20 weeks in the dermaPACE group, and the rate of healing was maintained in the dermaPACE group at 24 weeks. This full 24-week information was filed with the Company’s PMA submission to the FDA.
In its recent letter, the FDA cited, among other deficiencies, the dermaPACE study’s previously disclosed failure to meet the study’s primary endpoint of 100% wound closure compared with Sham-control at the 12-week time point. Among the letter’s recommendations to address the above cited deficiency is for SANUWAVE to design and conduct another clinical trial using the findings from any subgroup(s) that may support the safety and effectiveness of the dermaPACE device. The Company is evaluating the comments in the FDA’s letter and is considering its formal response, which may include submitting answers to the deficiencies based on further analysis of the existing data. The Company will continue to evaluate how additional clinical data could further support the approvability of the dermaPACE PMA and will discuss with the FDA whether such data will be required and supportive. The Company anticipates that its evaluation of its response to the letter and its associated interactions with the FDA will take place in the first quarter of 2012.