Hyanalgese-D topical gel data

HYALF announced that preliminary Phase III results for the analgesic gel failed to show overnight action in reducing pain. As a result, the company said, regulatory submissions may be delayed 12 months by the need for more trials.

Previous testing in 350 patients had shown superior pain relief over placebo or a positive control when efficacy was measured during the daily dosing period. But in the new data, from 400 patients, none of five assessment parameters reached statistical significance 12 hours after the last treatment. The gel was applied four times a day for up to four weeks. ...