The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of bupivacaine and meloxicam (Zynrelef) for the treatment of postoperative pain from small- to medium-sized surgical wounds.
Bupivacaine works as a local anesthetic. Meloxicam, a nonsteroidal anti-inflammatory drug, enhances the efficacy of bupivacaine. Zynrelef uses a proprietary biochronomer polymer delivery system to slowly release these drugs over a period of roughly 72 hours.
In two phase 3 studies, the bupivacaine/meloxicam fixed-dose combination achieved significant reductions in pain and opioid use through 72 hours compared with bupivacaine solution, the current standard of care for postoperative pain management, Heron Therapeutics BC, the manufacturer, said in a news release.
The combination also significantly reduced pain intensity and use of opioid medications following surgery and significantly increased the proportion of patients who required no postoperative opioid medications.
In both studies, bupivacaine/meloxicam was generally well tolerated, with a safety profile comparable to placebo and bupivacaine solution, the company said.
“Managing postoperative pain remains a major challenge for many physicians, given that up to 80% of patients across report moderate to severe pain for several days after surgery,” Richard Langford, MD, St. Bartholomew’s Hospital, Barts Health NHS Trust, London, United Kingdom, said in the release.
He noted that surgical pain “causes avoidable suffering” that can lead to longer hospital stays and higher healthcare costs.
“The indication recommended by the CHMP will allow surgeons to use the product for a wide range of surgeries, enabling a broad range of patients to benefit from the prolonged action of this important product,” said Langford.
Once approved, Zynrelef will be available as prolonged-release wound solutions of 60 mg/1.8 mg, 200 mg/6 mg, and 400 mg/12 mg.
The CHMP recommends that the drug be administered in settings in which trained personnel and equipment are available to promptly treat patients who show evidence of neurologic or cardiac toxicity.
Generic for MS Walking Disability
At its July meeting, the CHMP also recommended approval for Fampridine Accord to improve walking of adults with multiple sclerosis (MS) and walking disability, defined as a disability resulting in a score of 4 to 7 on the Expanded Disability Status Scale.
Fampridine Accord is a generic version of Fampyra, which has been on the market in the European Union since July 2011.
“Studies have demonstrated the satisfactory quality of Fampridine Accord and its bioequivalence to the reference product Fampyra,” the EMA noted.
Detailed recommendations for these products will be given in the summary of product characteristics, which will be published in the European public assessment report. It will also be made available in all official European Union languages if marketing authorization is granted by the European Commission.