New formulation: Tapentadol extended release tablets were FDA approved for the management of moderate-to-severe chronic persistence pain requiring continuous maintenance in adults.
On August 26, 2011, FDA approved the twice-daily tapentadol extended-release tablets for the management of moderate-to-severe chronic persistence pain requiring continuous maintenance in adults.
Efficacy. The efficacy of Nucynta ER was evaluated in 4 randomized controlled clinical trials, 1 in osteoarthritis of the knee (n=1,023, 12-week duration), 1 in patients with diabetic peripheral neuropathy (n=588, 12-week duration), and 2 in patients with lower back pain and osteoarthritis (n=1,117, up to 1-year duration). Each clinical trial evaluated pain reduction on an 11-point numerical scale as the primary end point, and in each study, pain was reduced significantly more with Nucynta ER compared to placebo.
Safety. In clinical trials the most common adverse events occurring in >10% of Nucynta ER patients were nausea (21%), constipation (17%), dizziness (17%), headache (15%), and somnolence (12%). As with other opioids, respiratory depression should be watched for closely, particularly in the elderly, debilitated, or those suffering from conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve (eg, asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma). Other serious adverse effects of Nucynta ER include hypotension, elevations in intracranial pressure, heightened seizure risk, and serotonin syndrome (particularly with concomitant administration of SSRIs, SNRIs, monoamine oxidase inhibitors, tricyclic antidepressants or triptans). Since coadministration with alcohol can result in elevated serum levels of Nucynta ER, the 2 should not be taken together to prevent a potentially fatal overdose. The risk of Nucynta ER misuse, abuse, and diversion is similar to other opioid analgesics.