Merck & Co has been given the go ahead in the USA to market its Emend drug to treat nausea and vomiting in patients who undergo surgery, increasing the number of patients eligible to receive treatment with the product.
The new indication comes after Emend (aprepitant) was approved in 2003 to treat nausea and vomiting caused by cancer chemotherapy. With the latest approval, Emend can be used in the 30% of patients who experience these symptoms after surgery.
Merck said it compared Emend with GlaxoSmithKline’s widely-used antinausea drug Zofran (ondansetron) in 1,658 patients undergoing open abdominal surgery. Among the patients receiving an oral, 40mg dose of Emend one to three hours before anesthesia, 84% did not experience vomiting through 24 hours, compared to 71% of patients given Zofran as a 4mg intravenous dose immediately before anesthesia.
Approval for use in surgical patients should add some sales momentum to Emend, which brought in $87 million in sales for Merck last year, still a long way short of the $1.5 billion that GSK earned from Zofran sales. Sales growth for the product is also expected to gather speed following the FDA’s approval of its use in a broader spectrum of cancer chemotherapies earlier ths year.
A European Commission advisory committee voted to recommend approval of Emend to prevent post-operative nausea and vomiting in March.
Latest Vioxx trial coming to an end
Meanwhile, the Atlantic City jury in the latest lawsuit broight by patients claiming damages from Merck’s withdrawn Vioxx (rofecoxib) painkiller has heard closing arguments and could deliver its verdct as early as today.
Merck now faces more than 13,000 Vioxx-related lawsuits and has vowed to fight them one by one. It has lost three trials so far, with juries awarding multimillion-dollar damages in each case. The company has said it plans to appeal those verdicts.