Summary
- Qutenza is a flexible film that wraps on the skin and leads to a rapid release of 8% capsaicin.
- Possible applications: OA, Post-herpetic neuralgia, HIV neuropathy, and diabetic neuropathy.
- The results show efficacy in both post-herpetic neuralgia and HIV neuropathy as determine by 30% decrease in pain.
- More trials are being presently conducted.
- NeurogesX is developing a liquid form is that is works in a much shorter time (5 min instead of the current 30 to 60 min).
Analysis
- Approval in Europe will not accelerate approval by the FDA. This is because the guidelines for approval are different by agencies in USA vs.. Europe.
- In Europe comparison with a known active compound is required.
- In Europe if efficacy is shown in one type of peripheral neuropathy (HIV) then approval is usually granted for all peripheral neuropathies.
- Qutenza received approval by the European Commission in May 2009 for the treatment of HIV neuropathy, but not yet for diabetic neuropathy, which is a much larger market.
- In the USA applications must be filed to the FDA for each types of neuropathy.
- Another issue is that the FDA considers capsaicin as a new compound; therefore it has to meet all the criteria of a new compound before going to market.
Luc Jasmin consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
