* Shares up 5.6 pct in premarket trading (Adds analyst comment)
CHICAGO, Jan 7 (Reuters) – A small, mid-stage trial of Qnexa, an experimental weight-loss drug developed by Vivus Inc (VVUS.O), showed it reduced the incidence of sleep apnea events by 69 percent, the company said on Thursday.
Shares of the company jumped 5.6 percent to $9.75 in premarket trading.
Vivus, based in Mountain View, California, filed last week for U.S. regulatory approval of Qnexa as a treatment for obesity.
“This could potentially expand the market opportunity, but first and foremost it is being developed as a weight-loss drug, which is under review,” Canaccord Adams analyst Adam Cutler said.
“An important point is that (the reduction in) sleep apnea is likely due to weight loss. The two are linked. It’s not clear how (Vivus) will proceed to get the label specifically for sleep apnea. It’s likely they will need to do more studies,” Cutler said.
A weight-loss indication alone, however, could easily give Qnexa blockbuster drug status, he said, but there is no near-term catalyst for the stock until the U.S. Food and Drug Administration decides whether to approve the drug, so Cutler said he maintains a “hold” rating.
“I’m optimistic, but there’s no rush to buy the stock,” he added.
STUDY SHOWS DROP IN INCIDENCE
The company said a 28-week study involving 45 obese patients suffering from obstructive sleep apnea, or OSA, found that treatment with Qnexa led to a drop in the number of apnea/hypopnea events to a mean of 14 per hour of sleep from 46 per hour. The number of events for placebo patients fell from a mean of 44 events per hour to 27 per hour.
Qnexa-treated patients lost 10.2 percent of their body weight, compared with weight loss of 4.3 percent for placebo patients. The drug also led to improvements in blood pressure, and overnight blood oxygen levels, according to Vivus.
The most common side-effects were dry mouth, altered taste and sinus infection, the company said.
Qnexa combines relatively low doses of the generic stimulant phentermine and epilepsy drug topiramate, which is sold under the brand name Topamax. It is a capsule designed to release the components so that side-effects are minimized.
Phentermine was part of the fen-phen diet drug cocktail. Two other drugs used in the cocktail were recalled after they were linked to heart damage.
Sleep apnea is caused by a collapse of the upper airway during sleep. It is closely linked with obesity, high blood pressure, heart failure, stroke and death.
The National Sleep Foundation estimates that 18 million Americans have sleep apnea, for which current treatment involves devices or surgery. There are no approved pharmaceutical treatments.
Vivus said Qnexa, in addition to weight loss, may improve OSA through other mechanisms and it plans additional studies. “We also look forward to meeting with the FDA to discuss the results of this study and to determine the regulatory path for approval,” Vivus Chief Executive Leland Wilson said in a statement. (Reporting by Deena Beasley in Los Angeles and Debra Sherman in Chicago; Editing by Steve Orlofsky, Dave Zimmerman)