This excerpt taken from the NGSX 8-K filed Nov 17, 2009.
NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
First and only prescription strength capsaicin product can provide up to 12 weeks of reduced pain from a single one-hour treatment
San Mateo, Calif., (November 16, 2009) NeurogesX, Inc. (NASDAQ: NGSX) announced today that the U.S. Food and Drug Administration (FDA) has approved 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. 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.
PHN can be an excruciatingly painful condition that can affect many aspects of a patients quality of life. Despite a variety of medications for pain, undesirable side effects often limit their use and therefore, the treatment of PHN continues to represent a significant unmet need, said Lynn Webster, M.D., Medical Director, Lifetree Clinical Research, Salt Lake City, Utah. 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.
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. Up to four patches may be used and patches may be cut to conform to the size and shape of the painful area. Qutenza is a locally-acting, non-narcotic medication that is unlikely to cause drowsiness or have drug-drug interactions. Treatment with Qutenza may be repeated every three or more months as warranted by the return of pain.
In clinical trials, the most common adverse reactions were application site redness, pain, itching, and papules. The majority of these reactions were transient and self limited. Among patients treated with Qutenza, one percent discontinued prematurely due to an adverse event. Serious adverse reactions included application site pain and increased blood pressure. Increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes were on average less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal.
We are delighted to have received the FDAs approval to provide this novel pain management therapy to the many patients and physicians looking for new ways to manage PHN, said Anthony DiTonno, President and Chief Executive Officer, NeurogesX. 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.
NeurogesX plans to commercialize Qutenza in the United States through its own sales force and plans for the initial launch of Qutenza in the first half of 2010.