New Option for the Management of Acute Painby Jennifer Gibson, PharmD | December 13, 2008
Acute pain affects more than 25 million Americans each year, and is one of the primary reasons that people seek medical care. Acute pain may result from injury, trauma, surgery, or medical procedures, and can have significant emotional, cognitive, and sensory consequences. Though acute pain, by definition, is short-lived, it can have significant and detrimental effects on the patient’s quality of life and can lead to chronic pain if left untreated. Up to half of post-operative patients in the United States receive inadequate pain control. This leads to delayed mobilization and increased risk for deep vein thrombosis and pulmonary embolism.
There have been very few advances in the drug treatment options available for acute pain in the last decade, and opioids or narcotics, such as morphine, oxycodone, and hydrocodone, and non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, are the mainstays of acute pain management. Now, however, a new option is on the horizon. In November of 2008, the FDA approved a new pain reliever for the management of acute pain. Tapentadol is an immediate-release oral tablet for the treatment of moderate to severe acute pain. It is available in doses of 50 mg, 75 mg, and 100 mg. Studies are currently underway to evaluate a controlled-release formulation of tapentadol.
Tapentadol is unlike most other pain relievers, as it has 2 modes of action: it activates the opioid receptors in the brain, spinal cord, and gastrointestinal tract, and also inhibits the reuptake of norepinephrine in the brain. Tramadol is the other so-called “multimodal analgesic” that functions similarly: it also activates opioid receptors, and inhibits the reuptake of both norepinephrine and serotonin in the brain. This dual mechanism of action leads to fewer gastrointestinal side effects than traditional pain relievers, and offers a decreased likelihood of tolerance to the drug.
Tapentadol, like all opioid-based therapies, has some risk of dependence, abuse, and addiction. It is safe and effective when used and monitored appropriately in patients, but will require monitoring by health care professionals to determine the appropriate dose and length of therapy. Like all opioids, caution is advised when taking tapentadol with alcohol, illicit drugs, and other opioid medications.
FDA approval of tapentadol follows clinical trials involving more than 2000 patients. Many studies have evaluated tapentadol versus traditional pain relievers following orthopedic and dental surgeries. Overall, tapentadol was as effective, or more effective, than current therapies, and patients experienced few side effects. The most common side effects were those expected with opioid-based treatment: nausea, dizziness, vomiting, sleepiness, and headaches.
Tapentadol is manufactured by Johnson & Johnson; a brand name has not been determined. Before tapentadol is available for use, it must be reviewed by the United States Drug Enforcement Agency to determine its classification as a controlled substance.
FDA Approves New Drug to Alleviate Moderate to Severe Pain; FDA News, 2008.
Regina Kleinert, Claudia Lange, Achim Steup, Peter Black, Jutta Goldberg, Paul Desjardins (2008). Single Dose Analgesic Efficacy of Tapentadol in Postsurgical Dental Pain: The Results of a Randomized, Double-Blind, Placebo-Controlled Study Anesthesia & Analgesia, 107 (6), 2048-2055 DOI: 10.1213/ane.0b013e31818881ca
Jens-Ulrich Stegmann, Horst Weber, Achim Steup, Akiko Okamoto, David Upmalis, Stephen Daniels (2008). The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery Current Medical Research and Opinion, 24 (11), 3185-3196 DOI: 10.1185/03007990802448056
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