Merck & Co has unveiled plans to submit its new insomnia drug suvorexant for regulatory approval in the USA this year.
The US major noted that the drug, an investigational orexin receptor antagonist, has come through two Phase III trials and it plans to submit these data at major medical meetings later this year. The results would appear to be positive as a New Drug Application for suvorexant with the US Food and Drug Administration will be filed in 2012.
Merck has continued to invest heavily in R&D, at a time when many of its peers are cutting back, and says suvorexant is one of the five major US filings it plans this year and in 2013. The others are Tredaptive (extended-release niacin/laropiprant) for atherosclerosis, the osteoporosis treatment odanacatib, a cervical cancer vaccine called V503 and Bridion (sugammadex), for the reversal of neuromuscular blockade.
Research head Peter Kim noted that suvorexant "selectively targets an important pathway involved in helping to promote sleep and, if approved, will be a new, first-in-class treatment for patients with insomnia". He added that "we look forward to sharing the results from these studies with the medical community".