Nuvo Research Inc., has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application filed May 27, 2011 for a novel topical Lidocaine Spray formulation (NRI-ANA), allowing for initiation of Phase 1 studies.
NRI-ANA is being developed for the treatment of an acute neuropathic pain condition using molecular skin penetration enhancers identified by Nuvo scientists.
These transdermal carriers deliver the active drug through the skin directly to the site of pain, potentially offering site-specific pain therapy while limiting systemic exposure with the potential to reduce negative side effects, adverse events and potential drug-drug interactions. International patent applications are pending.
Clearance of the NRI-ANA IND provides Nuvo with an additional development option as it completes a thorough review of its internally developed pain pipeline product candidates, as well as those recently acquired through the acquisition of ZARS Pharma, Inc.
The Company is actively prioritizing these product pipeline opportunities based on several criteria and will provide additional information on pipeline decisions after a comprehensive evaluation.