NeurogesX Provides Update on NGX-1998 Clinical Program

SAN MATEO, Calif., April 11, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. NGSX, a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's request for an End-of-Phase 2 meeting to discuss the continued clinical investigation of NGX-1998 as a treatment for certain neuropathic pain conditions including, specifically, the Company's plans for entering NGX-1998 into Phase 3 development. The Company anticipates that the End-of-Phase 2 meeting will occur in the third quarter of 2012. 

NGX-1998, NeurogesX' most advanced product candidate, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. The Company believes that the clinical data obtained to date should support moving to a Phase 3 clinical development program, which it believes can be initiated by the end of 2012. 

The Phase 2 study that NeurogesX completed at the end of 2011 was a 12-week, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Its protocol-specified objectives were met, including the primary endpoint of a percentage change from baseline as compared to placebo in a patient-reported numeric pain rating scale (NPRS) score during weeks two through eight. A total of 183 patients were treated in the Phase 2 study. Patients were randomized into one of three groups: NGX-1998 capsaicin 10% solution, NGX-1998 capsaicin 20% solution or placebo, according to an unequal allocation scheme of 2:2:1.  NGX-1998 exhibited a dose response. Although no topical anesthetic was used during the second stage of the study, the patients were able to tolerate the treatment procedure. No patients discontinued the study due to adverse events, and the incidence of adverse events and serious adverse events in patients treated with NGX-1998 were similar to the placebo-treated group.

About NeurogesX, Inc.

NeurogesX, Inc. NGSX is a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies to address unmet medical needs and improve patients' quality of life.  

The Company's lead product, Qutenza^®, is currently approved in the United States and the European Union. Qutenza^® is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza^® is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The Company's 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 clinical trials and one Phase 2 clinical trial in PHN patients, and the Company believes that NGX-1998 is ready to enter Phase 3 development.

The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.

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 statements regarding: the sufficiency of currently held data to support moving NGX-1998 development into Phase 3, the potential entry of NGX-1998 into Phase 3 development by the end of 2012; and the timing of the End-of-Phase 2 meeting with the FDA.  Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: NGX-1998 may fail to demonstrate sufficient safety or efficacy in clinical trials to support further development or potential marketing approval; potential delays of the End-of-Phase 2 meeting with the FDA; difficulties or delays in the initiation of clinical trials for NGX-1998; Qutenza, NGX-1998 and NeurogesX' other product candidates may have unexpected adverse side effects; NeurogesX may have insufficient resources to pursue clinical development of NGX-1998; and difficulties or delays in NeurogesX' efforts to engage in strategic relationships with respect to development or commercialization of Qutenza or NGX-1998.  For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.