Two-component pharmaceutical composition for the treatment of pain

Abstract

The present invention is directed to a pharmaceutical composition that includes a combination of about 2-5 milligrams of a non-steroidal anti-inflammatory drug and from about 2-30 milligrams of an opioid analgesic in a single pharmaceutical dosage unit that can provide effective pain management with the added benefit of reduced side effects such as withdrawal and gastrointestinal disorders. The non-steroidal anti-inflammatory drug may be piroxicam and the opioid analgesic may be buprenorphine. The present invention also provides for a method of managing pain in a patient that includes administering the pharmaceutical composition previously described. The pharmaceutical composition previously described may be administered in a single or multiple dosage regimen.

Description

[0001] The invention relates generally to a pharmaceutical dosage unit having a therapeutically effective amount of a non-steroidal anti-inflammatory drug in combination with a therapeutically effective amount of an opioid analgesic that can be used for the treatment of pain with reduced side effects such as opioid withdrawal and gastrointestinal irritation and damage. More particularly, the pharmaceutical dosage unit includes piroxicam in combination with buprenorphine for sublingual administration. BACKGROUND OF THE INVENTION [0002] Pain is prevalent. It is estimated that more than 50 million Americans live with chronic pain caused by various diseases or disorders, and each year nearly 25 million people suffer with acute pain as a result of injury or surgery. Furthermore, chronic pain has been said to be the most costly health problem in America. Estimated annual costs, including direct medical expenses, lost income, lost productivity, compensation payments, and legal charges are ...

AI Technical Summary

Benefits of technology

[0007] The present invention is directed to a pharmaceutical composition that includes a combination of a non-steroidal anti-inflammatory drug such as piroxicam and an opioid analgesic such as buprenorphine in a pharmaceutical dosage unit that provides safe and effective pain management with the added benefit that side effects such as gastrointestinal tract damage and withdrawal as a result of physical dependence and / or addiction are reduced. In one embodiment, the invention is a pharmaceutical combination of a low effective amount of piroxicam and a high effective amount of buprenorphine. In another embodiment, the pharmaceutical composition is a combination of about 2-5 milligrams of a non-steroidal anti-inflammatory drug such as piroxicam and about 2-30 milligrams of an opioid analgesic such as buprenorphine for sublingual administration.

Problems solved by technology

Furthermore, chronic pain has been said to be the most costly health problem in America.

Thus, pain management has been identified as one of the most difficult challenges for the health care industry.

NSAIDs are well absorbed following oral administration but there is a high potential for adverse side-effects such as ulcerations, abdominal pain, cramping, nausea, gastritis, kidney disease, angiodema, pancreatitis, and even serious gastrointestinal bleeding and liver toxicity at the upper limits of their effective dose ranges.

Thus, the ability to use higher dosages of NSAIDs is generally limited.

Moreover, above each NSAIDs' upper limit or ceiling, administration of additional NSAID or use of combinations of NSAIDs does not usually increase the analgesic or anti-inflammatory effect.

While narcotic analgesics vary considerably in their chemical structures and pharmacological properties, almost all suffer the disadvantages of tolerance and possible addiction with continued usage.

Consistent with its agonist action at opioid receptors, however, partial agonists such as buprenorphine are still abusable, particularly by individuals who are not already physically dependents on opioids.

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