NeurogesX Inc., a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, provided an update on its regulatory process for NGX-1998, the company’s next generation liquid formulation of prescription-strength capsaicin. NeurogesX has received End-of-Phase 2 guidance from the U.S. Food and Drug Administration (FDA) regarding its previously announced plans for the Phase 3 clinical development of NGX-1998 as a treatment for neuropathic pain conditions, including key elements of its overall development plan related to manufacturing, applicator development, and clinical trial design.
Ronald Martell, President and CEO, stated, “We are pleased with our recent interaction with the FDA. We have been working closely with the agency, and they have provided us with the guidance we need regarding our NGX-1998 development program, including Phase 3 trial design, manufacturing (CMC) plans and applicator development. Based on this guidance, we can now proceed toward achieving our goal of enabling the Phase 3 trial by the end of this calendar year. Additionally, this guidance represents a key element of clarity that we expect will support our partnering goals for NGX-1998.”
Stephen J. Peroutka, M.D., Executive Vice President and Chief Medical Officer, added, “We are very appreciative of the agency’s assessment of our proposed development program. We believe that an opportunity exists to leverage both our internal expertise in neuropathic pain and the large body of data that we have accumulated and that is still being generated with Qutenza. Taken together, we believe that these factors will allow for a focused and efficient development path for NGX-1998.”
Date: August 7, 2012
Source: NeurogesX Inc.
Filed Under: Drug Discovery