MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology was developed by Axsome to alter the pharmacokinetics of a potentially therapeutic molecule. Drug molecules that are low in solubility have slow and/or poor absorption in the stomach leading to a decreased time to peak plasma concentrations (Tmax). Absorption is similarly affected by ionization of the drug molecule, which is a function of pH. Using patented technology, we created a buffered drug-carrier complex combined with a pH modifier to significantly improve the rate and degree of drug absorption.
Phase 1 Results using MoSEIC™ Technology
This Phase 1 study assessed the pharmacokinetics of meloxicam after oral administration of AXS-06 tablets (meloxicam 15 mg, esomeprazole 40 mg) compared to concurrent administration of commercially available Mobic® (15 mg meloxicam) tablets and Nexium® (40 mg esomeprazole). In healthy volunteers, the median Tmax for meloxicam was measured to be 9 times faster following AXS-06 administration compared to Mobic® and Nexium® (0.5 hours versus 4.5 hours, p<0.0001). The long half-life of meloxicam was maintained in AXS-06 at approximately 20 hours.
The time to maximum plasma concentration (Tmax) of MoSEIC™ meloxicam was comparable to the Tmax of intravenous (infusion) meloxicam at 15 minutes.