Merck experimental insomnia drug suvorexant looks safe and is effective at helping patients fall asleep more quickly and to stay asleep, advisors to the FDA said yesterday. Panelists voted 13-3 that starting doses (15 mg in elderly and 20 mg in non-elderly) are safe, despite evidence from the company that the pill can cause daytime sleepiness and difficulty driving. Separately, the committee voted against the higher doses (30 mg in elderly and 40 mg in non-elderly). FDA staffers had raised issues with the drug’s higher doses prior to the meeting of the outside panel, FDA’s peripheral and central nervous system advisory committee. The agency doesn’t always follow the advice of its advisors. Submitted to the FDA last fall, suvorexant works by blocking orexin receptors, a different mechanism of action from the non-benzodiazepines like Sanofi’s Ambien, which leads the sleep market as a generic, as well as Sunovion’s Lunesta and King’s Sonota, all of which work by stimulating the neurochemical GABA.
Forest Labs CEO and President Howard Solomon will retire in December, ending his long tenure at the helm of the pharma company, according to a statement. The company said it’s evaluating internal and external candidates and hopes to name a successor before the end of the year. Solomon has served as CEO since 1977 and has been with the New York firm nearly 50 years, the last few of which he’s been mired in battles with HHS and with activist investor Carl Icahn. Management praised “the launches of a new generation of products, all advanced under Howard’s stewardship,” which have included Linzess for IBS and Turdoza for COPD in 2012, and Viibryd for depression in 2011. Solomon is expected to remain as chairman through the 2014 Annual General Meeting, at which time another chairman will be elected and Solomon will become chairman emeritus, the company said.
