Patent ID: 8329216

Claim:
An oral controlled release oxymorphone formulation, comprising: a. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt of oxymorphone; and b. a hydrophilic material, wherein upon oral administration of the formulation to a subject in need of an analgesic effect: (i) the formulation provides detectable blood plasma levels of 6-OH oxymorphone and oxymorphone; (ii) the blood plasma levels of 6-OH oxymorphone and oxymorphone peak within about 1 hour to about 8 hours after administration; (iii) the blood plasma levels of 6-OH oxymorphone and oxymorphone exhibit a ratio of area under the curve (AUC (0 to inf) ) of blood plasma level versus time for 6-OH oxymorphone compared to oxymorphone in a range of about 0.5 to about 1.5; (iv) the duration of the analgesic effect is through at least about 12 hours after administration; and (v) the blood plasma levels of oxymorphone exhibit two or three peaks within about 12 hours after administration.