On Thursday Feb 9, 2012 the FDA Anesthetic and Analgesic Advisory Committee will review the supplemental application from Neurogesx for QUTENZA (capsaicin). The company is asking for approval of an additional label claim for treatment of pain associated with HIV neuropathy. The drug already has an approved claim for treatment of pain of post-herpetic neuralgia.
The company is seeking approval of the 8% formulation being used for 30 minutes. The drug was tested at doses of 4% and 8% for durations of 30, 60 and 90 minutes. There are only two problems with this application. The first is that the studies showed little or no dose response. This is not good if one is seeking an approval. The second problem is that the drug only showed a benefit when administered for 90 minutes. This is not if you are seeking a treatment duration of 30 minutes.
The FDA made the effort in their review to cite the Regulations for effectiveness. This is not good either. I guess that really makes three problems!