NeurogesX plans pan-European filing for Transacin patch

Published: 8-Aug-2006

The European Medicines Evaluation Agency's Committee for Medicinal Products for Human Use (CHMP), has confirmed that pain-killing dermal patch Transacin is eligible for submission for Community (Centralised) Marketing Authorisation in Europe.


The European Medicines Evaluation Agency's Committee for Medicinal Products for Human Use (CHMP), has confirmed that pain-killing dermal patch Transacin is eligible for submission for Community (Centralised) Marketing Authorisation in Europe.

California-based pharmaceutical company NeurogesX, which developed the patch, plans to file a marketing application in early 2007.

The 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 physician-administered patch contains 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. It reduces the potential for safety issues or side effects that negatively impact quality of life is expected to be low.

NeurogesX is applying for simultaneous licensure in all 25 EU member states. The approval process is expected to require approximately 12 months from the time of the filing.

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