NeuroDiscovery Ltd, an Australian neurology-focused research and development company, has announced that two Phase II clinical trials of NSL-101 have commenced.
The first trial is for the treatment of pain after the surgical extraction of wisdom teeth. The second trial is for the treatment of pain after the scaling and root planing procedure for periodontitis.
Both studies are being conducted at the Peruvian University of Cayetana Heredia in Lima and the first patients have been enrolled into the trials and received treatment.
These clinical trials are both Phase II double-blind, randomized studies which will evaluate the analgesic efficacy of NSL-101 in patients suffering pain after either the extraction of one or more wisdom teeth, or scaling and root planing for periodontitis. The analgesic efficacy of NSL-101 post wisdom tooth extraction will be compared to placebo, and pain post scaling and root planing will be compared to the standard analgesic used in this procedure. Further details on both trials are included in the appendix.
Subject to recruitment, it is anticipated that the periodontitis trial will finish in Q1 2008 and the wisdom tooth extraction trial will finish in Q2 2008. Results will be made available in Q2 and Q3 2008 respectively.
“There is a significant medical need for new more analgesics to treat pain after oral surgery” said David McAuliffe, Executive Director of NeuroDiscovery. “These Phase II trials for NSL-101 demonstrate our commitment and ability to move our therapies swiftly through clinical trials. If we obtain positive results for both trials currently underway we will have an excellent data package to present to potential licensees”