Oxymorphone controlled release formulations

A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.05 ng/ml and about 5.0 ng/ml upon oral administration of a single dose to a subject.

A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 0.02 ng/mg·ml at about 12 hours after oral administration of a single dose to a subject.

40 The controlled release oxymorphone formulation of claim 39 wherein said formulation contains about 5 mg oxymorphone.

The controlled release oxymorphone formulation of claim 40 wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 0.13 ng/ml at about 12 hours after oral administration of a single dose to a subject.

A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.010 ng/mg·ml at about 12 hours after oral administration of a single dose to a subject.

A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein upon repeated oral administration of said formulation to a subject every 8 to 12 hours through steady state conditions, said formulation provides a minimum blood concentration of oxymorphone of at least about 0.025 ng/mg·ml at about 12 hours after administration.

A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein upon repeated oral administration of said formulation to a subject every 8 to 12 hours through steady state conditions, said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.03 ng/mg·ml at about 12 hours after administration.

A method of controlling pain in a patient for 8 hours comprising administering to said patient a single dose of a pharmaceutical preparation comprising from about 5 mg to about 80 mg oxymorphone which induces in the patient a blood plasma concentration of oxymorphone of at least 0.02 ng/mg·ml at least 12 hours after said administration.

A method of controlling pain in a patient for 8 hours comprising administering to said patient a single dose of a pharmaceutical preparation comprising from about 5 mg to about 80 mg oxymorphone which induces in the patient a blood plasma concentration of 6-OH oxymorphone of at least 0.014 ng/mg-ml at least 12 hours after said administration.

A controlled release pharmaceutical formulation comprising a controlled release matrix and about 5 to about 80 mg oxymorphone wherein the relative bioavailability of oxymorphone to an equal dose of an immediate release formulation of oxymorphone is from about 0.5 to about 1.5 upon oral administration of a single dose to a subject.

A controlled release pharmaceutical formulation comprising a controlled release matrix and about 5 to about 80 mg oxymorphone wherein the ratio of the area under the blood plasma concentration versus time curve of 6-OH-oxymorphone to oxymorphone, from time 0 to infinity (AUC(0-inf)) is in the range of about 0.5 to about 1.5 upon oral administration of a single dose of the formulation to a subject.

A controlled release pharmaceutical formulation comprising a controlled release matrix and about 5 to about 80 mg oxymorphone wherein upon repeated oral administration of said formulation to a subject every 8 to 12 hours through steady state conditions, the ratio of the area under the blood plasma concentration versus time curve of 6-OH-oxymorphone to oxymorphone, from time 0 to infinity (AUC(0-inf)) is in the range of about 0.5 to about 1.5 upon oral administration a last dose of the formulation to a subject.