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Tapentadol: FDA Approves New Opiate Painkiller

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Many Americans dealing with pain will soon have a new option when it comes to managing it. The U.S. Food and Drug Administration approved a new immediate-release tablet for the management of moderate to severe pain.

Tapentadol hydrochloride is a synthetic analgesic available in doses of 50 mg, 75 mg and 100 mg. An FDA press release from Nov. 24 says the drug “acts in two ways, opioid (narcotic) and non-opioid.” It reportedly activates opioid receptors in the brain, spinal cord and gastrointestinal tract, and inhibits the reuptake of the brain chemical norepinephrine which may have an analgesic effect. The FDA lists side effects for Tapentadol as nausea, vomiting, dizziness and sleepiness.
Labeling on the packaging warns users of the risk of respiratory depression and its potential to be abused. It can also have addictive depressive effects on the central nervous system when taken with alcohol, other opiates or illicit drugs, the FDA said.

As with Other Opiates, New Drug has Potential for Abuse
Tapentadol is manufactured by Janssen Ortho, LLC, in Gurabo, PR., a subsidiary of Johnson & Johnson. It will be available once the U.S. Drug Enforcement Agency classifies the controlled substance in its drug schedule. The FDA says opiates are “safe and effective in selected patients but can cause dependence, abuse and addiction.” Approval was based on clinical studies of more than 2,100 patients presented earlier this year at the annual scientific meeting of the American Pain Society. The studies found Tapentadol to provide significant relief when compared to a placebo. A trade name for Tapentadol has not yet been established.

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