Skip to main content

FDA Turns Down Capsaicin Patch for Painful Neuropathy in HIV


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."

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

CareFusion Issues Update on Infant Breathing Product Recall

July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its Air Life ™ Infant Breathing Circuit, initiated back in May. The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units. The update was posted July 2 on the FDA  Website. On May 29, 2012, CareFusion sent an  Urgent Recall Notice  to customers and distributors stating that the company had identified potential risks associated with the Air Life  Infant Breathing Circuit. The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing cracks during patient use. "If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volum...
Post a Comment
Read more

FDA Approves Tapentadol ER for Diabetic Neuropathy

August 29, 2012 — The US Food and Drug Administration (FDA) has approved tapentadol extended-release (ER) ( Nucynta , Janssen Pharmaceuticals, Inc) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults for whom a continuous opioid analgesic is required over an extended time. It is the first opioid to receive this indication, the company notes in a statement today. DPN, the most common type of neuropathy, affects an estimated 16% of the more than 25 million Americans who have diabetes. The condition is often unreported and untreated, with an estimated 2 out of 5 cases not receiving care. Tapentadol ER is already approved for the treatment of moderate to severe chronic pain in adults requiring a continuous opioid analgesic for an extended period. It is a centrally acting synthetic analgesic, although the exact mechanism of action is unknown, the release states. "Although the clinical relevance is unclear," the company n...
4 comments
Read more