Merck & Co’s nausea and vomiting therapy Emend is effective in preventing chemotherapy-induced nausea and vomiting (CINV) even when given as a single dose, says a new study.
The 1,000-patient trial revealed that a 150mg injection of neurokinin 1 antagonist Emend (fosaprepitant dimeglumine) was more effective than placebo – both given in combination with oral anti-vomiting drugs ondansetron and dexamethasone – in patients taking moderately-emetogenic chemotherapy (MEC).
The single-dose regimen is already approved for use in highly-emetogenic chemotherapy (HEC), but Merck says it will now file the results with regulators later this year to broaden Emend’s use to include chemotherapy regimens less prone to causing sickness.
All told, 79% of Emend treatment had a complete response – defined as no vomiting or use of additional medications to control nausea in the two to five-day period after chemotherapy – compared to 68.5% of the placebo group.
“Nausea and vomiting remain a significant burden for patients receiving chemotherapy and we look forward to submitting these data for Emend for injection to the FDA,” said Stuart Green, vice president of clinical research at Merck Research Laboratories.
Emend has been a solid product for Merck & Co, with sales last year rising 9% to reach $553m, but is approaching the end of its patent life. The US patent for the oral formulation expires this year, but the injectable remains protected until 2019, according to Merck.
The injectable formulation has been challenged however, with Merck filing a lawsuit in 2012 seeking to block a generic developed by Sandoz, and subsequent suits filed against Accord Healthcare/Intas and Fresenius.
An automatic 30-month stay on launch of the Sandoz generic comes to an end next month, although the litigation is still moving through the court process. The 30-month stays on the launch of the other generics come to an end next year.
In the meantime Merck is also facing a challenge on its injectable patent from Apotex, which filed a petition with the US Patent and Trademark Office (USPTO) last December.
Generics aside, competition is building in the CINV sector. Last October the FDA approved Eisai’s combination Akynzeo (netupitant and palonosterol), while Tesaro’s oral and injectable NK1 antagonist rolapitant was submitted for approval last September.