Sepracor moves toward marketing drug in Europe

Sepracor Inc., the Marlborough drug maker, said today that a committee of regulators has recommended that its Lunivia insomnia drug be approved for marketing in the European Union.

But Sepracor's chief executive said he would ask the committee to re-examine its opinon in a way that would "enable more favorable commercialization of the product."

Sepracor noted that Lunivia is widely marketed in the United States under the brand name of Lunesta. With a glowing green moth used as a brand icon, Lunesta was widely ranked as the most heavily advertised drug in the United States in recent years, but now Sepracor is scaling back its marketing budget for the drug as Lunesta comes under pressure from generic competition and slower-than-expected demand, a recent Globe story noted.

In its announcement today, Sepracor said that the European Medicines Agency 's Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion recommending to grant a marketing authorization for LUNIVIA brand eszopiclone in the European Union for the treatment of insomnia.

Sepracor said, "The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short-term."

"We are pleased with the CHMP's decision to support approval of Lunivia in the EU, a decision that we feel reflects the regulatory agency's satisfaction with the quality, safety, and efficacy of the product in both the short and long-term treatment of insomnia," Adrian Adams, Sepracor president and chief executive, said in a statement. "However, we are considering requesting a re-examination of the opinion relating to the exclusion of a new active substance designation that we feel would enable more favorable commercialization of the product."
(By Chris Reidy, Globe staff)