Instituut voor Neuropathische Pijn

In a recent press release (18-10-2010) it was communicated that the company NeurogesX  U.S.will try to broaden the indications for Qutenza® (capsaicin) 8% patch to include patients with painful HIV-associated neuropathy (HIV-AN, also referred to as HIV-distal sensory polyneuropathy (HIV-DSP)). Following a recent meeting with the U.S. Food and Drug Administration (FDA), NeurogesX plans to submit a supplemental new drug application (sNDA) in the first half of 2011.

This is based on two completed Phase 3 studies in patients with HIV-AN.

Qutenza® is currently indicated in the U.S. for the management of neuropathic pain associated with postherpetic neuralgia (PHN), and has been evaluated in two Phase 3 studies in patients with HIV-AN.

The FDA has previously granted orphan drug designation for the use of capsaicin to treat painful HIV-AN and fast track designation for Qutenza for the treatment of painful HIV-AN.

Capsaicine in such a high topical dose kills of for some weeks the thin fibers conducting pain. It is a bit of a crude method, and the application of the plaster is not very simple. However, patients suffering from intractabale pain, were topical low dose capsaicine is not effective, might find help from the plaster.

Oktober 2010, Jan M. Keppel Hesselink, MD, PhD