Two phase II clinical trials commence for NeuroDiscovery
A neurology-focused research and development company, is pleased to announce 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"
About NSL-101 & Dental Surgery
NeuroSolutions has collaborated with Ampika Ltd to develop further knowledge of Peruvian medicinal plants with a view to capitalising on opportunities offered by herbal formulations. NSL-101 was identified from the Ampika database of medicinal plants as a natural product formulation that is effective in alleviating the symptoms of dental pain. The product has been used in documented, empirical form for more than 5 centuries as a dental analgesic in Peru, with anti-inflammatory effects. The detailed studies of its electrophysiology demonstrate that a preparation of NSL-101 inhibits the discharges of the damaged nerves associated with pain. NeuroSolutions owns NSL-101 via a worldwide-exclusive licence.
The third molar or wisdom tooth is a source of pain for many people worldwide. The pain and associated with the extraction of a wisdom tooth is well-known. On average, after surgical extraction, 60% of patients experience moderate pain and 40% experience severe pain before asking for an analgesic drug. The non-steroidal anti-inflammatory drugs (NSAIDs) are used extensively for the control of pain after minor surgery and are effective for acute and chronic pain but unwanted side effects such as gastrointestinal intolerance can often appear.
In the United States alone the amount spent on wisdom tooth extraction is estimated to be more than $2 billion, excluding the costs of examinations, x-rays, medicine, anaesthetics, or charges in surgical centres or hospitals. In addition the lost time at work is considered to be from one to six days, with an average of a day of lost wages.
Periodontitis is an infectious disease that affects the gums. The main target of the scaling and root planing procedure is to recover gum health by completely removing plaque that produces gum inflammation. This is called scaling. The tooth surface is then planed so it is smooth. This allows the gums to regenerate without irritation.
Reference: NeuroDiscovery Ltd is an ASX listed neurology research and development company which owns 100% of NeuroSolutions Ltd (ASX Code NDL).
