NeurogesX has received approval from FDA for Qutenza (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles.
NeurogesX plans to commercialise Qutenza in the US through its own sales force and plans for the initial launch of Qutenza in the first half of 2010.
Reportedly, Qutenza delivers a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, through a dermal delivery system, providing up to 12 weeks of reduced pain following a single one-hour application. It is the first product from NeurogesX to be approved by the FDA.
Qutenza works by targeting certain pain nerves in the area of skin where pain is being experienced. The Qutenza patch is applied by a physician or a healthcare professional. Clinical studies have shown that PHN pain can be reduced for up to 12 weeks following a single one-hour treatment.
Anthony DiTonno, president and chief executive officer of NeurogesX, said: “The approval of Qutenza is a tremendous accomplishment for NeurogesX as it represents the culmination of numerous years of hard work and determination by our entire organization.
“With Qutenza now approved both in the United States and European Union, we expect 2010 will be a great year for NeurogesX as Qutenza is introduced in these major markets.”
Lynn Webster, medical director of Lifetree Clinical Research, said: “Qutenza may provide a unique treatment option that works at the site of the pain and may be useful as a treatment option in combination with existing therapies.”