$heff's $tation of $tocks & $olid DD

[bob smith]

ngsx misses the boat, this time.....

http://www.bloomberg.com/news/2012-02-09/neurogesx-fails-to-win-u-s-fda-panel-backing-for-patch-to-treat-hiv-pain.html?cmpid=yhoo

NeurogesX Inc. (NGSX), a specialty drugmaker that has never reported an annual profit, failed to win the backing of a U.S. advisory panel for its patch to relieve painful nerve damage commonly associated with HIV.

The panel voted 12-0 that the San Mateo, California-based company didn’t provide substantial evidence that the product, Qutenza, works. The advisers to the U.S. Food and Drug Administration met today in Silver Spring, Maryland

The FDA staff raised questions in a report Feb. 7 whether the prescription-strength capsaicin patch proved “substantial efficacy” in treating pain caused by neuropathy linked to the virus. NeurogesX filed studies with the FDA that used alternative testing methods to show a “modest benefit,” said Randall Flick, associate professor of anesthesiology at the Mayo Clinic in Rochester, Minnesota, and acting panel chairman.

“I was really concerned about setting a precedent going forward, that bothered me a lot,” said Penney Cowan, executive director of the American Chronic Pain Association in Rocklin, California, and the panel’s acting consumer representative.

The FDA typically only accepts post-hoc studies it does itself, Bob Rappaport, director of FDA’s division of anesthesia, analgesia and addiction products.

Seeking Flaws
“We’re not biased when we’re doing these things,” Rappaport said. “We’re looking for the flaws.”

Rappaport called the lack of evidence “heartbreaking.”
“We’ll do our best to work with the sponsor to come up with the best and most efficient trial to hopefully get this approved in the not-too-distant future,” he said.

One-third of people with HIV/AIDS experience peripheral nerve damage caused by the virus or drugs used to treat it, according to the Center for Peripheral Neuropathy at the University of Chicago. More than 1.1 million in the U.S. are estimated to be infected with HIV, according to the Atlanta- based Centers for Disease Control and Prevention.

The FDA is scheduled to decide whether to approve Qutenza by March 7. The agency doesn’t have to follow the advisory panel’s recommendation.

No FDA-approved drugs exist for HIV-associated neuropathy, according to NeurogesX. Painkillers and narcotics are recommended to treat the condition, according to the Center for Peripheral Neuropathy. Capsaicin is the chemical that makes chili peppers hot.

The FDA approved Qutenza in November 2009 for lasting pain after a shingles infection. The product sells for $675 a patch and has almost 1,000 customers, Anthony DiTonno, former president and chief executive officer, said at the Lazard Healthcare Conference, according to a Nov. 18 transcript.

The FDA found one test showed Qutenza worked when used for 90 minutes and failed to show effectiveness when used for an hour or 30 minutes. Later analyses based on alternative testing showed the 30-minute application worked, the agency said.

Qutenza failed to show efficacy in hourlong and 30-minute uses in a second study, according to FDA’s staff report. Again using alternative testing later, the patch showed it worked in the 30-minute application.

To contact the reporter on this story: Anna Edney in Washington at [e-mail].

To contact the editor responsible for this story: Adriel Bettelheim at [e-mail].