What Is Tapentadol?
Tapentadol is a centrally-acting, immediate-release, synthetic analgesic (pain) medication. Tapentadol was approved for the relief of moderate to severe acute pain in adults who are 18 years and older.
Tapentadol has two mechanisms of action -- combining mu-opioid receptor agonism and norepinephine reuptake inhibition. Essentially, tapentadol activates opioid receptors in the brain, spinal cord, and gastrointestinal tract.
Is Tapentadol Available Now?
Tapentadol has been approved in 50 mg, 75mg, and 100 mg doses. The brand name of the drug is Nucynta. It is manufactured by Johnson & Johnson.
Which Studies Support the Approval of Tapentadol?
The approval of tapentadol was based on several phase III studies that included more than 2,100 study participants. The studies assessed the effectiveness of tapentadol in various groups including those who had:
The studies concluded that tapentadol provided significant pain relief when compared to placebo.
Are There Any Safety Warnings Associated With Tapentadol?
You should not use Tapentadol if you are experiencing significant respiratory depression, acute and severe bronchial asthma or hypercapnia (too much CO2 in the blood). The drug should not be used in patients with paralytic ileus or in patients currently taking a MAOI or within 14 days of using and MAOI.
Tapentadol should also not be used by patients with increased intracranial pressure, impaired consciousness, or coma. It should be used with caution in patients with liver problems. Elderly patients should start out at a dose that is lower.
What Common Adverse Events Are Associated With Tapentadol?
The most common adverse events (greater than 10%) in any tapentadol group in clinical trials included nausea, dizziness, vomiting, sleepiness and headache.
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain. Johnson & Johnson Pharmaceutical Research and Development. 11/21/2008.
FDA Approves New Drug to Alleviate Moderate to Severe Pain. FDA News. 11/24/2008.