AstraZeneca Pharmaceuticals announced this week that it has received approval from the US Food and Drug Administration for 72-hour infusion of Naropin (ropivacaine HCL), a long-acting anesthetic indicated for the production of local or regional anesthesia for surgery, post-operative pain management and for obstetrical procedures.
The company received approval for two changes in Naropin labeling: the first allows for dose increase from 5.0 mg/mL to 7.5 mg/mL for Major Nerve Blocks; the second grants approval for an increase in the duration of Naropin infusion from 24 hours to 72 hours for post-operative pain management.
"The 72-hour infusion indication allows pain management to extend well into the post-operative area with tremendous benefits to patients," said Roy Allan Greengrass, M.D., Associate Professor for the Department of Anesthesiology at Duke University. "It further reduces the need for pain management with opioids and can ultimately result in enhanced patient satisfaction."
Naropin is the only long acting anesthetic with a 72-hour infusion indication. In clinical trials the most commonly reported adverse events were hypotension, nausea, vomiting, bradycardia, fever, paresthesia and back pain.
Pain management is one of AstraZeneca's six therapeutic areas of focus. Other products developed and manufactured by AstraZeneca include Diprivan (propofol) Injectable Emulsion, EMLA (Lidocaine 2.5% and Prilocaine 2.5%), EMLA Anesthetic Disc (Lidocaine 2.5% and Prilocaine 2.5%) Topical Adhesive System and Xylocaine (Lidocaine HCl Injection, USP).
Prescribing information for Naporin is available in today's issue.