The primary task of the study is to evaluate the biodistribution of indomethacin, the active ingredient in Indaflex, after either oral or topical administration of appropriate formulations in equal doses.
The AlphaRx drug delivery system is designed to improve the historically poor penetration of indomethacin through the skin while avoiding the side-effects involved with the oral dosing formulation. Indomethacin concentration in the system is 11 times lower for topical administration than for oral, thus reducing possible gastrointestinal side effects.
Indaflex is a topical NSAID (non-steroidal anti-inflammatory drug) formulation intended for use in the treatment of the symptoms of arthritis. Clinical development of the drug is AlphaRx’ principal focus at this time, although the company already markets the topical pain drug Flexogan and the heart drug CoQ10ER.