NeurogesX’ Qutenza(TM) (NGX-4010) Receives Positive Committee Recommendation in European Union
Broad Label Indicated for Peripheral Neuropathic Pain in Non-Diabetic Adults
Conference Call Scheduled
Qutenza is a high-concentration capsaicin dermal patch designed to provide rapid, localized and sustained relief from peripheral neuropathic pain. The CHMP’s positive recommendation will be evaluated by the European Commission, and a decision on marketing authorization is expected in the next 60 to 90 days.
The CHMP’s positive opinion recommending approval of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults was made in reliance on NeurogesX’ commitment to conduct certain post-marketing studies. These post-marketing commitments, which are often required by the CHMP as a condition of an approval recommendation, may include an open-label safety study of Qutenza in on-label indications, as well as a clinical safety and efficacy study in painful diabetic neuropathy.
Conference Call Details
The Company will hold its quarterly conference call on
A live web cast of the call will also be available from the Investor Relations section on the corporate web site at http://www.neurogesx.com. A web cast replay can be accessed on the corporate web site beginning
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 suffers from neuropathic pain. Treatments to address the estimated 6.0 million U.S. neuropathic pain suffers generated over
Despite the large pain population and sizeable market opportunity in neuropathic pain, current treatment options are limited by the need for frequent dosing, undesirable systemic side effects, and unsatisfactory relief.
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, that the Company believes offers significant advantages over other pain therapies. 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, the expected timing of the European Commissions decision on the CHMP’s recommendation for approval of the MAA for Qutenza in the European Union; NeurogesX’ plans to seek and timing to obtain a commercial partner for Qutenza in
NeurogesX, Inc. The Ruth Group Stephen Ghiglieri Stephanie Carrington / Sara Ephraim (investors) Chief Financial Officer (646) 536-7017 / 7002 (650) 358-3310 email@example.com firstname.lastname@example.org Jason Rando (media)/Janine McCargo (646) 536-7025/7033 email@example.com firstname.lastname@example.org
SOURCE NeurogesX, Inc.