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

Antidepressants Linked to Higher Diabetes Risk in Kids

Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report. In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article  published online October 16 in  JAMA Pediatrics . The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants. The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution. They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our know...
Post a Comment
Read more

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

FDA Decision Delayed for Truvada in HIV PrEP

June 11, 2012 — The US Food and Drug Administration (FDA) has delayed its decision on allowing the use of tenofovir disoproxil fumarate/emtricitabine ( Truvada , Gilead) as preexposure prophylaxis (PrEP) so that the proposed risk evaluation and mitigation strategy (REMS) can be reviewed. In early May, the FDA's Antiviral Drugs Advisory Committee  strongly backed  approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection. However, concerns by the panel at the time included that people may neglect condom use if they feel they are protected by PrEP. Panelists were also concerned that uninfected people taking PrEP who become infected with HIV may not switch to a 3-drug regimen as recommended. According to the company, the FDA has postponed the target date to September 14 so it can review Gilead's REMS plan to help ensure that patients will not misuse the drug. The committee's recommendation for supplemental approval of tenofovir/emtricit...
Post a Comment
Read more