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Denmark's Lundbeck has won European approval for the alcohol dependence drug Selincro (nalmefene), a new approach to fighting addiction which it had in-licensed from Finland's Biotie. But don't expect to see it in the U.S. anytime soon.
The drug is an opioid receptor antagonist, designed to break the brain's reward mechanism when alcoholics drink. And rather than preventing drinking, it's expected to help reduce alcohol dependence.
"Selincro represents the first major innovation in the treatment of alcohol dependence in many years," said EVP Anders Gersel Pedersen, the R&D chief at Lundbeck. "The approval of Selincro is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment." Marketing of the drug is expected to launch in mid-2013.
In one trial the drug was linked with a drop in the number of heavy drinking days from 19 to 7, with total alcohol consumption sliding from 84 g to 30 g after 6 months. In the placebo arm, binge drinking days slid from 20 to 10, though, and total alcohol consumption dropped from 85 g to 43 g. In a separate study, heavy drinking days slid from 20 to 7 while consumption dropped from 93 g to 30 g, while the placebo group registered an 18 to 7-day drop in drinking days and an 89 g to 33 g drop in consumption. In a third study, the drug arm barely edged the placebo at 6 months. All the subjects in the trial were given medical advice about their drinking habits.
Lundbeck has expressed high hopes for the blockbuster potential of Selincro, but most analysts don't expect it to be a big winner. Thomson Reuters has noted that the top peak sales forecast hovers around $300 million a year. But any new revenue is welcome at Lundbeck, which has been hammered after cutting its revenue and profit forecast for the year.
Lundbeck has no plans to file for an approval in the U.S. In the past it's cited the FDA for a bias against new drugs for addiction as well as an absence of 10-year market exclusivity rights, which it has in Europe.
- read the press release
- here's the Reuters story