FDA Turns Down Capsaicin Patch for Painful Neuropathy in HIV

Emma Hitt, PhD

March 09, 2012

March 9, 2012 — The US Food and Drug Administration (FDA) has issued a complete response letter for a supplemental new drug application proposing a label expansion of capsaicin 8% patch (Qutenza, NeurogesX, Inc) to treatment of pain related to peripheral neuropathy in patients with HIV.

The patch, a dermal delivery system containing 8% capsaicin, is the company’s lead product and was approved in 2009 in the United States and the European Union for the treatment of pain from postherpetic neuralgia.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee almost unanimously recommended against granting the expanded indication for HIV-related peripheral neuropathy pain last month. The complete response letter from the FDA based on this vote was received by the company March 7.

During the FDA panel meeting on February 9, the 12-member committee was asked to discuss the safety and efficacy of the patch and finally to vote on the question "based on the currently available data, is the risk-benefit profile acceptable for Qutenza to be approved for this indication?" In response, 11 members voted "no" and 1 member abstained.

In a previous vote, the committee had unanimously voted "no" in response to the question "Do the data from the 2 clinical trials, C107 and C119, provide substantial evidence of effectiveness of Qutenza for the management of neuropathic pain associated with HIV-peripheral neuropathy?"

"I think we really need to know that something is helpful for folks who are desperate before we approve it," said panel member Edward C. Covington, MD, director of the Neurological Center for Pain, Cleveland Clinic Foundation in Ohio.

Currently, the company is evaluating a 20% capsaicin topical liquid formulation, called NGX-1998, which may provide similar efficacy and safety as Qutenza, but is applied for 5 minutes and then removed, without the need for a topical anesthetic pretreatment.

"The Company believes the clinical data obtained to date should support moving to a phase 3 clinical development program following an end-of-phase 2 meeting with the FDA for NGX-1998," the company writes in a news release. NeurogesX believes they could initiate phase 3 development near the end of 2012.

"We are convinced that focusing our resources on our NGX-1998 development program has the potential to generate greater shareholder value in the long term," stated Stephen Ghiglieri, executive vice president, chief operating officer, and chief finance officer.

"With respect to Qutenza, we remain committed to continuing its availability," Ghiglieri noted. Trials are currently under way in collaboration with Astellas Pharma in pain associated with diabetic neuropathy and "if those studies are successful, they could potentially provide a further opportunity for label expansion."

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