NeurogesX Receives European Commission Approval for Qutenza(TM)
Approved for peripheral neuropathic pain in non-diabetic adults
The approval of Qutenza follows a positive opinion recommending approval from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) on
NeurogesX anticipates that Qutenza will be marketed in the European Union through a commercial partner.
About Neuropathic Pain
Neuropathic pain is a type of chronic pain that results from injury to, or dysfunction of, nerves in the central or peripheral nervous systems. Peripheral neuropathic pain is an inappropriate sensation of pain that results when injured or dysfunctional nerve endings send aberrant pain signals to the brain, in the absence of harmful stimuli. It can result from viruses, in cases of postherpetic neuralgia (PHN) and painful HIV-distal sensory polyneuropathy (HIV-DSP), or diseases, such as diabetes.
An estimated 8% of the world’s population and an estimated 3.0 million people in
Peripheral neuropathic pain syndromes can be difficult to treat and current treatment options may be limited by the need for frequent dosing and undesirable systemic side effects.
About NeurogesX, Inc.
NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX’ late stage product portfolio is led by its product candidate Qutenza, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. NeurogesX submitted a new drug application (NDA) for Qutenza to the U.S. Food and Drug Administration (FDA) in
NeurogesX’ second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently evaluating the timing of entering Phase 2 development.
NeurogesX’ early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, NeurogesX’ plans to seek and timing to obtain a commercial partner for Qutenza in
NeurogesX, Inc. Stephen Ghiglieri Chief Financial Officer (650) 358-3310 The Ruth Group Sara Ephraim (investors) (646) 536-7002 firstname.lastname@example.org Jason Rando (media)/Janine McCargo (646) 536-7025/7033 email@example.com firstname.lastname@example.org
SOURCE NeurogesX, Inc.