About Ostrolux™
3V Medical Research Group is developing Ostrolux™, a cream for the treatment of chronic pain. It is highly suitable for transdermal absorption without a need for an active delivery system or complex patch. Topical administration to obtain a systemic effect avoids first- pass metabolism in the liver and may be associated with a reduced incidence of side effects.
CAUTION: OSTROLUX™ IS AN INVESTIGATIONAL NEW DRUG. IT IS NOT APPROVED BY THE FDA OR ANY OTHER REGULATORY BODY. IT IS NOT AVAILABLE FOR USE OUTSIDE CLINICAL STUDIES. THE STATEMENTS ON THIS WEB SITE HAVE NOT BEEN REVIEWED OR APPROVED BY THE FDA.
Ostrolux’s main ingredient is known to have an analgesic effect with a mechanism of action involving binding at opiate receptor sites.
Few side effects from using Ostrolux have been observed based upon limited clinical experience to date. GLP-compliant repeat-dose toxicity studies did not reveal any toxicity in mini pigs. No evidence of genotoxicity was noted in GLP-compliant studies in peripheral human lymphocytes or rat bone marrow after exposure to Ostrolux. In addition, no sensitization after application of Ostrolux Cream was noted in a GLP-compliant guinea pig sensitization study.
Taken together, the data from the GLP-compliant studies, in combination with the extensive preclinical literature concerning the safety of our active pharmaceutical ingredient (API), indicate that Ostrolux Cream is expected to be safe for application to humans.
A study of Ostrolux has been performed, evaluating the Safety and Efficacy of Ostrolux Cream in the treatment of pain associated with osteoarthritis of the knee. The data seem promising. There have been no significant negative safety signals.
Potential risks include irritation of treated skin.