FDA Approves Dual-Action Analgesic for Moderate to Severe Acute Pain

By Peggy Peck
ROCKVILLE, 30 nov 2008-- The FDA announced today it has approved a centrally acting oral analgesic, Tapentadol hydrocholoride, for relief of moderate to severe acute pain.
The drug combines mu-opioid receptor agonism with norepinephrine reuptake inhibition in a single molecule.
The FDA approved an immediate release formulation of the drug in 50-mg, 75-mg, and 100-mg doses.
The agency said the approval offered "health care professionals an additional choice for treating moderate to severe acute pain."
The most common side effects reported with Tapentadol were nausea, dizziness, vomiting, sleepiness, and headaches.
The FDA said the Tapentadol label will include warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential.
The drug is marketed by Johnson & Johnson of New Brunswick, N.J.