FDA Concerned with Effectiveness of NeurogesX's (NGSX) Qutenza Patch
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Shares of NeurogesX (Nasdaq: NGSX) have plunged nearly 21 percent in Tuesday's pre-market session as the FDA has raised concerned related to the effectiveness of the company's Qutenza patch.
From the FDA:
At this meeting of the AADPAC we will be discussing a supplemental application to NDA 022395, submitted by NeurogesX, Inc. in support of their proposal to add a new indication to the product labeling for Qutenza. Qutenza is an 8% capsaicin patch which was approved for the treatment of the pain of post-herpetic neuralgia in November of 2009. This supplement requests approval to expand the indication to include treatment of the pain associated with HIV neuropathy.
The sponsor has provided the results of two adequate and well-controlled clinical trials of Qutenza. Both studies employed the requested label dose (8%) compared to a very low dose capsaicin patch (0.04%) over different time-exposures. Study C107, evaluated the change from baseline average pain over 12 weeks after patch application for 30, 60 or 90 minutes. Study C119 again evaluated the change from baseline pain over 12 weeks, but after patch application for only 30 and 60 minutes. C107 did demonstrate a statistically significant treatment effect at 90 minutes, based on the pre-specified statistical analysis plan, but it failed to demonstrate statistical significance for the 30 and 60 minute applications compared to the low-dose control patch. Study C119 failed to achieve statistical significance on the pre-specified primary outcome analyses for either application time. In addition, the control patches applied for longer durations appeared to provide pain relief compared to baseline and to the Qutenza patches in both studies, in spite of the very low dose of capsaicin in these patches. The sponsor is requesting approval for Qutenza with patch application for 30 minutes. Statistical concerns regarding multiplicity, and the absence of replicated statistically significant results have raised the question of whether evidence of substantial efficacy has been demonstrated for this proposed treatment regimen.
From the FDA:
At this meeting of the AADPAC we will be discussing a supplemental application to NDA 022395, submitted by NeurogesX, Inc. in support of their proposal to add a new indication to the product labeling for Qutenza. Qutenza is an 8% capsaicin patch which was approved for the treatment of the pain of post-herpetic neuralgia in November of 2009. This supplement requests approval to expand the indication to include treatment of the pain associated with HIV neuropathy.
The sponsor has provided the results of two adequate and well-controlled clinical trials of Qutenza. Both studies employed the requested label dose (8%) compared to a very low dose capsaicin patch (0.04%) over different time-exposures. Study C107, evaluated the change from baseline average pain over 12 weeks after patch application for 30, 60 or 90 minutes. Study C119 again evaluated the change from baseline pain over 12 weeks, but after patch application for only 30 and 60 minutes. C107 did demonstrate a statistically significant treatment effect at 90 minutes, based on the pre-specified statistical analysis plan, but it failed to demonstrate statistical significance for the 30 and 60 minute applications compared to the low-dose control patch. Study C119 failed to achieve statistical significance on the pre-specified primary outcome analyses for either application time. In addition, the control patches applied for longer durations appeared to provide pain relief compared to baseline and to the Qutenza patches in both studies, in spite of the very low dose of capsaicin in these patches. The sponsor is requesting approval for Qutenza with patch application for 30 minutes. Statistical concerns regarding multiplicity, and the absence of replicated statistically significant results have raised the question of whether evidence of substantial efficacy has been demonstrated for this proposed treatment regimen.
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