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.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
Read More
ICER Gives Cell Therapy for Post-Transplant Complications High Rating
Published: October 31st 2024 | Updated: October 31st 2024ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
Read More