A year after enduring a stinging FDA rejection, Merck has convinced the agency to sign off on lower doses of its suvorexant, a novel sleep drug once predicted to become a blockbuster.
Merck has cut one of most advanced efforts to develop a new therapy for Parkinson's disease. Its Phase III clinical trials of preladenant for the prevalent neurological disorder failed to beat placebo, prompting the U.S. drug giant ($MRK) to halt extension studies of the experimental A2A receptor agonist and abandon plans to file for regulatory approvals for the treatment.
A panel of experts assembled by the FDA has given Merck a boost in its quest for an approval of the sleep drug suvorexant.
FDA staffers found clear evidence to prove that Merck's blockbuster drug candidate suvorexant is quite effective in promoting sleep, but the internal review cites multiple safety issues for the high doses studied in clinical trials.
Billed by some--though certainly not all--analysts as a likely blockbuster, the pharma giant has been enthusiastic about spreading word of Suvorexant's positive late-stage data from a pair of Phase III studies. And now researchers are back talking up a new animal study that purports to do what Phase III never did--compare it to popular generic drugs that now dominate a shrinking market.
Merck is in a world of hurt. The pharma giant managed to spook several analysts with the news that its osteoporosis drug odanacatib would be held back from regulators until more data could be obtained in a trial extension, raising fears that the badly needed drug may be about to jump the tracks.
The regulatory road to the FDA is littered with the burned wreckage of once-promising sleep drug programs. Merck, though, is making an ambitious bid to change the entire game on sleep drugs.
Merck unveiled a full slate of Phase III data on its experimental sleep drug suvorexant, claiming a success in safely promoting a good night's rest among patients suffering from insomnia. And the pharma giant's team leader on the project says the late-stage results pave the way for an NDA later this year on one of the biggest late-stage drug prospects in its pipeline.
Merck has touted the performance of one of its late-stage contenders as the drug giant readies an application for U.S. approval of the experimental insomnia drug.
Merck today says it has the late-stage data it needs to gain an approval for a new insomnia drug, one of 5 treatments the pharma giant believes it can gain an official OK on before the end of 2013....