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NeurogesX Receives Confirmation of Transacin Eligibility for EU Centralized Market Submission; Centralized Procedure Enables Pan European Filing |
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02 Aug 2006 |
SAN CARLOS, CA, USA | Aug 01, 2006 | NeurogesX, Inc., a privately held specialty pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP), a scientific committee of the European Medicines Evaluation Agency (EMEA), has confirmed that a marketing application for Transacin(TM) is eligible for submission for Community (Centralized) Marketing Authorization in Europe. The committee cited Article 3(2)b of Regulation (EC) No. 726/2004, which requires an application for a Centralized Marketing Authorization to be a "Significant Technical Innovation." Transacin is NeurogesX's proprietary, novel high concentration trans-capsaicin dermal patch currently being developed for the treatment of neuropathic pain.
NeurogesX plans to file a Transacin marketing application with the EMEA for a broad label in peripheral neuropathic pain in early 2007. This application will include data from a previously reported Phase 3 study in HIV-associated sensory neuropathy (HIV-AN) combined with results from an ongoing Phase 3 study in postherpetic neuralgia (PHN). The company plans to file its submission for Transacin through the centralized procedure - one of three procedures under which companies can apply for marketing authorization within the European Union. By filing Transacin via the centralized procedure, NeurogesX is applying for simultaneous licensure in all 25 European Union member states. The approval process is expected to require approximately 12 months from the time of the filing.
"The EMEA's recognition of Transacin as a significant technical innovation allows us to quickly and efficiently pursue market approval throughout the EU, which we expect will expedite commercialization of Transacin across Europe and provide caregivers with a potentially important alternative for treating patients suffering from peripheral neuropathic pain conditions," said Anthony A. DiTonno, NeurogesX president and CEO.
NeurogesX is currently evaluating marketing and distribution collaborations outside the United States.
About Transacin (NGX-4010)
Transacin is a topical, physician administered patch containing a high concentration of trans-capsaicin, a synthetic form of the naturally occurring TRPV1 agonist capsaicin. Unlike current treatment approaches for neuropathic pain that include opioids and other agents acting on the central nervous system that can cause drowsiness or other systemic side effects, the patch is designed to act peripherally in the skin, where the pain frequently originates. Due to the novel patch delivery system and dermal site of action of Transacin, the potential for safety issues or side effects that negatively impact quality of life is expected to be low. In a Phase 3 study in HIV-associated sensory neuropathy (HIV-AN), Transacin showed statistically significant reductions in pain (p=0.0025) compared to a low concentration comparator. This study result was announced in May 2005.
About NeurogesX
NeurogesX is a privately held specialty pharmaceutical company focused on the development of novel treatments for the management of neuropathic pain. The company's initial products are focused on the treatment of chronic pain in the areas of postherpetic neuralgia (PHN), painful HIV-associated sensory neuropathy (HIV-AN) and painful diabetic neuropathy (PDN). Additional information about NeurogesX can be found at www.neurogesx.com.
NeurogesX is a trademark of NeurogesX, Inc. All other trademarks and registered trademarks are those of their respective companies.
SOURCE: NeurogesX, Inc. |
