A method of treating pain comprising administering a pharmaceutical formulation according to claim 3 to a patient in need thereof.

The pharmaceutical composition of claim 1 wherein about 45% to about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 4 hours in the test.

The pharmaceutical composition of claim 1 wherein at least about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 10 hours in the test.

An analgesically effective controlled release pharmaceutical composition with a twelve hour dosing interval in the form of a tablet, comprising oxymorphone or pharmaceutically acceptable salt thereof as the sole active ingredient in the tablet and a controlled release delivery system comprising a hydrophilic material that forms a gel upon exposure to gastrointestinal fluid, wherein upon placement of the composition in an in vitro dissolution test comprising USP Paddle Method at 50 rpm in 500 ml media having a pH of 1.2 to 6.8 at 37° C., about 15% to about 50%, by weight, of the oxymorphone or salt thereof is released from the composition at about 1 hour in the test, about 45% to about 80%, by weight, of the oxymorphone or salt thereof is released from the composition at about 4 hours in the test, and at least about 80%, by weight, of the oxymorphone or salt thereof is released from the composition at about 10 hours in the test. view more

The method of claim 18 wherein upon oral administration of the composition the oxymorphone AUC<sub>(o-inf) </sub>is no more than 20% higher when the composition is administered to the subject under fed as compared to fasted conditions.

An abuse-proofed, thermoformed dosage form comprising one or more active ingredients with abuse potential (A) optionally together with physiologically acceptable auxiliary substances (B), at least one synthetic or natural polymer (C), wherein the polymer (C) has a molecular weight of at least 0.5 million according to rheological measurements, and optionally at least one wax (D), wherein the dosage form exhibits a breaking strength of at least 500 N. view more

A dosage form according to claim 1, wherein the polymer (C) is at least one polymer selected from the group consisting of polyethylene oxide, polymethylene oxide, polypropylene oxide, polyethylene, polypropylene, polyvinyl chloride, polycarbonate, polystyrene, polyacrylate, copolymers and the mixtures thereof. view more

A dosage form according to claim 1, which additionally comprises at least one of the following components a)-f): (a) at least one substance which irritates the nasal passages and/or pharynx, (b) at least one viscosity-increasing agent, which, with the assistance of a necessary minimum quantity of an aqueous liquid, forms a gel with the extract obtained from the dosage form, which gel optionally remains visually distinguishable when introduced into a further quantity of an aqueous liquid, c) at least one antagonist for the active ingredient or active ingredients with abuse potential, (d) at least one emetic, (e) at least one dye as an aversive agent, (f) at least one bitter substance. view more

A dosage form according to claim 23, wherein component (C) and/or component (D) also serve as a controlled release matrix material.

A process for the production of a dosage form according to claim 1, comprising: mixing components (A), (B), (C) and the optionally present component (D) and the optionally present components (a) to (f) to form a resultant mixture, and press-forming the resultant mixture, optionally after granulation, to yield the dosage form with preceding, simultaneous, or subsequent exposure to heat. view more

A dosage form obtainable by a process according to claim 25.

The method according to claim 28, wherein the therapeutic condition is pain.

A dosage form according to claim 1, wherein the polymer (C) is polyethylene oxide having a molecular weight of from 1-15 million g/mol.

A dosage form according to claim 1, wherein the one or more active ingredients with abuse potential (A) is/are selected from the group consisting of oxymorphone, oxycodone, tapentadol and the physiologically acceptable salts thereof.

A dosage form according to claim 31, which is in the form of a tablet.

A dosage form according to claim 1, wherein the content of polymer (C) is at least 30% by weight relative to the total weight of the dosage form.

A dosage form according to claim 1, which is in the form of a tablet, wherein the one or more active ingredients with abuse potential (A) is/are selected from the group consisting of oxymorphone, oxycodone, tapentadol and the physiologically acceptable salts thereof; wherein the polymer (C) is polyethylene oxide having a molecular weight of from 1-15 million g/mol; and wherein the content of polymer (C) is at least 30% by weight relative to the total weight of the dosage form. view more

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. view more

The tablet of claim 21 wherein about 45% to about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 4 hours in the test, and at least about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 10 hours in the test. view more

The method of claim 38 wherein the difference in the oxymorphone area under the curve AUC<sub>(0-inf) </sub>between fed and fasted conditions is less than 20%.

The method of claim 38 wherein upon oral administration of the dosage form to the subject under fed or fasting conditions: (i) the dosage form 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; and (iii) the blood plasma levels of 6-OH oxymorphone and oxymorphone exhibit a ratio of AUC_(0-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. view more

The composition of claim 49 wherein upon oral administration thereof the oxymorphone AUC<sub>(0-inf) </sub>is no more than 20% higher when the dosage form is administered to the subject under fed as compared to fasted conditions.

The composition of claim 49 wherein about 45% to about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 4 hours in the test, and at least about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 10 hours in the test. view more

The composition of claim 55, wherein the composition is in the form of a tablet and wherein at least 27%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 1 hour in the test, at least 40%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 2 hours in the test, at least 50%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 3 hours in the test, at least 64%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 5 hours in the test, at least 70%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 6 hours in the test, at least 79%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 8 hours in the test, at least 85%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 10 hours in the test, and at least 89%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 12 hours in the test. view more

The composition of claim 55, wherein the composition is in the form of a tablet and wherein at least 70%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 6 hours in the test.

The composition of claim 55, wherein the composition is in the form of a tablet and wherein at least 85%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 10 hours in the test.

The composition of claim 66 wherein the composition is in the form of a tablet and about 45% to about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 4 hours in the test, and at least about 80%, by weight, of the oxymorphone or salt thereof is released from the tablet at about 10 hours in the test. view more

The pharmaceutical composition of claim 72 wherein about 45% to about 80%, by weight, of the oxymorphone or salt thereof is released from the composition after about 4 hours in the test.

The pharmaceutical composition of claim 72 wherein at least 80%, by weight, of the oxymorphone or salt thereof is released from the composition after about 10 hours in the test.

The pharmaceutical composition of claim 77 wherein upon oral administration of the dosage form to a human subject in need of an analgesic effect the blood plasma level of oxymorphone displays two or three peaks over about the first 12 hours after administration; and (i) the dosage form 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; and (iv) the duration of the analgesic effect is through at least about 12 hours after administration. view more

The pharmaceutical composition of claim 77 wherein about 58% to about 66%, by weight, of the oxymorphone or salt thereof is released from the composition after about 4 hours in the test.

The pharmaceutical composition of claim 77 wherein about 85% to about 96%, by weight, of the oxymorphone or salt thereof is released from the composition after about 10 hours in the test.

A method of treating pain in a subject in need thereof, the method comprising administering to the subject the pharmaceutical composition of claim 77 in an amount sufficient to provide the subject with about 5 mg to about 80 mg of oxymorphone or salt thereof. view more