NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced the completion of patient enrollment in its Phase 2 clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN). NGX-1998 is being developed to provide safety, efficacy and tolerability that is at least comparable to Qutenza® (capsaicin) 8% patch with a shorter treatment time. A total of 183 patients were enrolled in the Phase 2 study.
The Phase 2 clinical study design included two stages. The first stage was designed to determine the shortest tolerable anesthetic pretreatment regimen. The results of this stage of the study indicated that no topical anesthetic was required to achieve the study's tolerability goal. The second stage was designed to evaluate two NGX-1998 dose concentrations using the pretreatment regimens determined during stage 1. The objective of the second stage is to select the appropriate concentration of NGX-1998 for further evaluation in a Phase 3 clinical program.
Jeffrey Tobias, MD, Executive Vice President for Research and Development and CMO, commented, "With the completion of enrollment in our Phase 2 study, we are pleased to report another milestone in the development of NGX-1998, our liquid formulation of capsaicin. We expect that top-line data from the study will be available by year end. We are excited by the potential of NGX-1998 as it may be able to provide the benefits of high-concentration capsaicin in a rapid and convenient dosage form that should allow easy use by a broad range of healthcare providers."
NGX-1998 has been granted patent protection under a patent entitled "Methods and Compositions for Administration of TRPV1 Agonists." The allowed claims include method of use, formulation and system claims. The patent is set to expire in 2027, which includes patent term adjustment.