Methods of using meloxicam for pain treatment and management
The present invention relates to a method for managing pain, such as acute pain, post-operative pain, or post-procedure pain, by administering meloxicam.
1 . A method of treating moderate to severe pain in an individual in need thereof comprising administering a solid oral meloxicam composition to the individual, wherein the composition comprises an amount of meloxicam or a pharmaceutically acceptable meloxicam salt equivalent to 15 mg meloxicam, the individual's pain before administration of the composition is at a level the same as an adult human reporting a pain level of about from 4.0 to about 10.0 on a pain NRS, and the time to the individual's first meaningful pain relief is about 5.5 hours or less following administration of the composition.
2 . The method of claim 1 wherein the time to the individual's first meaningful pain relief is between about 2 hours to about 5.5 hours following administration of the composition.
3 . The method of claim 2 wherein the time to the first meaningful pain relief is between about 2.4 hours and 3.7 hours following administration of the composition.
4 . The method of claim 1 wherein the pain before administration of the composition is severe and is at a level the same as an adult human reporting a pain level of about 7.0 to about 10.0 on a pain NRS.
5 . The method of claim 1 wherein the pain before administration of the composition is moderate and is at a level the same as an adult human reporting a pain level of from about 4.0 to about 6.0 on a pain NRS.
6 . The method of claim 1 wherein the composition is administered to the individual about every 12 hours and wherein the individual's pain level decreases for about 48 hours after a first administration of the composition.
7 . The method of claim 1 wherein the pain comprises acute pain.
8 . The method of claim 1 wherein the pain comprises procedural pain.
9 . The method of claim 8 wherein the individual has undergone a surgery.
10 . The method of claim 1 wherein the composition is administered to the individual without food or when the individual is in a semi-fasted state.
11 . The method of claim 1 wherein the composition is administered to the individual about every 12 hours for 30 days or less.
12 . The method of claim 11 wherein the composition is administered to the individual about every 12 hours for 7 days or less.
13 . The method of claim 12 wherein the composition is administered four times to the individual about every 12 hours for 2 days (48 hours) or less.
14 . The method of claim 12 wherein the treatment is without significant risk to the individual of a gastrointestinal bleeding adverse event.
15 . The method of claim 12 wherein the treatment is without significant risk to the individual of a cardiovascular event.
16 . The method of claim 1 wherein the individual exhibits opioid-sparing behavior after administration of the composition.
17 . The method of claim 16 wherein the individual does not receive an opioid analgesic for at least about 48 hours after administration of the composition.
18 . The method of claim 1 wherein the individual does not receive a rescue pain medication before experiencing meaningful pain relief following administration of the composition.
19 . The method of claim 1 wherein the meloxicam or pharmaceutically acceptable meloxicam salt is in alkaline surroundings in the composition.
20 . The method of claim 1 wherein the composition comprises one or more alkalizing agents and one or more hydrophilic polymers.
21 . The method of claim 1 wherein the composition comprises sodium bicarbonate and an excipient selected from copovidone, hypromellose, or a combination of copovidone and hypromellose.
22 . The method of claim 21 comprising granules or pellets of meloxicam.
23 . A method of treating moderate to severe pain in an individual in need thereof comprising administering a solid oral meloxicam composition to the individual, wherein the composition comprises 15 mg of meloxicam, and wherein the individual's pain about 48 hours from the time of administration of the composition is relieved by a degree corresponding to a 48-hour summed pain intensity difference (SPID 0-48 ) of from about 163.0 to about 204.7 or from about 145.5 to about 180.7 using an 11-point NRS (zero to 10) for pain intensity.
24 . The method of claim 23 , wherein the individual feels pain at the time of administration of the composition at a level corresponding to about from 4.0 to about 10.0 using an 11-point NRS (zero to 10) for pain intensity.
25 . The method of claim 24 , wherein the composition is in the form of a tablet or tablets.
26 . A method of treating moderate to severe pain in an individual in need thereof comprising administering a solid oral meloxicam composition to the individual, wherein the composition comprises 15 mg of meloxicam, and wherein the composition provides a least squares mean summed pain intensity difference over 48 hours (least squares mean SPID 0-48 ) using an 11-point pain NRS (zero to 10) in a population of clinical study subjects of from about 163.0 to about 204.7 or from about 145.5 to about 180.7.
27 . The method of claim 26 wherein the individual feels pain around the time of administration of the composition at a level corresponding to about from 4.0 to about 10.0 on an 11-point pain NRS (zero to 10).
28 . The method of claim 26 wherein the composition is in the form of a tablet or tablets.
29 . The method of claim 27 wherein the composition is in the form of a tablet or tablets.