Breaking News
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

Vivus Stock Tumbles As FDA Defers Decision On Qnexa NDA

RELATED NEWS
Trade VVUS now with 
4/9/2012 8:16 PM ET

Shares of Vivus Inc. (VVUS: Quote) sank eight percent in extended hours on Monday, after the U.S. Food and Drug Administration extended by three months a decision on its obesity drug Qnexa.

The FDA now has set July 17, 2012 for a decision on the Qnexa New Drug Application. Earlier, the FDA had set an action date of April 17.

Vivus had recently indicated the submission of a Risk Evaluation and Mitigation Strategy for Qnexa and that the FDA extended the PDUFA date in order to review the submission.

Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine, a generic weight loss drug, and topiramate, used to treat epilepsy and migraines. If approved, Qnexa will will address weight loss, type 2 Diabetes and obstructive sleep apnea.

A FDA panel last February recommended approval of Qnexa for the treatment of obesity in adults, following which Vivus stock value nearly doubled.

The FDA initially had rejected Qnexa in 2010, citing potential cardiovascular problems and more chances of cleft lips in children born to women who conceive while taking the drug.

Vivus resubmitted Qnexa with longer-term data and analyzes. In phase 2 and 3 trials to date, Qnexa has shown efficacy with regard to weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with dietary and lifestyle changes.

FDA officials in their second review of Qnexa still cited concerns about potential risks for birth defects and heart problems, but acknowledged the drug's ability to help patients lose weight.

The market for anti-obesity drugs is virtually untapped, with a host of drugs failing to find favor with the FDA. The Agency last year rejected two experimental obesity pills -Arena Pharmaceuticals' (ARNA) Lorcaserin, and Orexigen Therapeutics' (OREX) Contrave.

Some approved pills like Abbott's (ABT) Meridia have been pulled from the U.S. market due to safety concerns. Roche's Xenical, a prescription anti-obesity drug and GlaxoSmithKline plc's (GSK) Alli, an over-the-counter weight-loss product are two FDA-approved drugs for obesity in the market.

VVUS closed Monday on the Nasdaq at $22.92, up $0.39 or 1.73%, on a volume of over 8.5 million shares. In after hours, the stock lost $1.79 or 7.81%. In the past year, the stock ranged between $6.13 and $25.14.

Register
To receive FREE breaking news email alerts for VIVUS INC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Housing starts in the U.S. showed a notable increase in the month of March, according to a report released by the Commerce Department on Wednesday, although starts still came in well below economist estimates. The report showed that housing starts climbed 2.8 percent to an annual rate of 946,000 in March from the revised February estimate of 920,000. After moving mostly higher over the course of the two previous sessions, stocks may see some further upside in early trading on Wednesday. The major index futures are currently pointing to a higher open for the markets, with the Dow futures up by 63 points. The U.K. unemployment rate fell below the 7 percent threshold to a five-year low in February and average earnings finally moved above inflation reducing the squeeze on household finances. The jobless rate came in at 6.9 percent of the labor force, the lowest since February 2009, data from the Office for National Statistics showed Wednesday.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.