IMMEDIATE RELEASE OXYMORPHONE COMPOSITIONS AND METHODS OF USING SAME
The present invention relates to compositions comprising oxymorphone or a pharmaceutically acceptable salt thereof and to methods of using such compositions to treat various conditions or disorders.
1 . An orally deliverable pharmaceutical composition comprising oxymorphone or a pharmaceutically acceptable salt thereof and a disintegrant, where upon administration of the composition to a group of subjects, the subjects exhibit one or more of the following:
(a) an average T max of oxymorphone within about 0.1 to about 3 hours after administration; (b) an average C max of about 0.25 to about 6.0 μg/ml; or (c) an average AUC 0-∞ (μg*h/I) of about 3 to about 25.
2 . A method of treating pain in a subject in need thereof, the method comprising administering a composition of claim 1 to the subject.
3 . The composition of claim 1 wherein the observed T max of oxymorphone is between about 0.1 and 1 hour.
4 . The composition of claim 1 wherein the observed average t 1/2 of oxymorphone is greater than about 7 hours.
5 . The composition of claim 3 wherein the observed average t 1/2 of oxymorphone is greater than about 7 hours.