Ardea Biosciences reports positive outcome from lesinurad End-of-Phase 2 meetings with FDA Ardea Biosciences, Inc here . announced that it offers completed formal End-of-Stage 2 meetings with the U.S. Meals and Medication Administration and effectively reached contract on the next key areas of its proposed lesinurad Stage 3 development program: the entire size and design of the planned Phase 3 clinical research, the primary endpoints, the total safety data source proposed for NDA filing, manufacturing programs for both drug element and drug product, the preclinical toxicology program and the medical pharmacology program.

‘We are on track to advance ARC-4558 for unpleasant diabetic neuropathy into Phase 3 studies and ARC-2022 into further Phase 1/2 research in 2012. ARC-4558 has received fast-track status with the FDA.’.. Arcion receives U.S. Patent allowance for ARC-2022 to take care of PHN Arcion Therapeutics, a clinical stage biotechnology company developing topical therapies for chronic pain, today announced that it received notice of allowance for a US Patent for its high power gel formulation of topical lidocaine, ARC-2022. ‘With ARC-2022 our goal is to provide lidocaine to the skin without the requirement of an occlusive patch.

Other Articles From "nutrition":

Random Articles