3V Medical Research Group is developing Ostrolux®, a cream for the treatment of chronic pain. It is highly suitable for transdermal absorption without the need of 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. Some topically applied drugs have been shown to be as, or more effective than the same agent delivered orally.
CAUTION: OSTROLUX (R) 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. Non-steroidal anti-inflammatory agents enhance this activity and the analgesic effect.
Few side effects from using Ostrolux are anticipated based upon limited clinical experience. 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. From these data, it can be reasonably concluded that Ostrolux Cream is not genotoxic. 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 effectiveness results seem promising. Similarly, there are no significant negative safety signals.
There are no known risks to humans associated with Ostrolux Cream. Potential risks include irritation of treated skin, and potential toxicity associated with the API.