Lundbeck Anti-Binge Drinking Drug Helps Cut Intake 66% in Clinical Trials

By Makiko Kitamura - Mon Mar 05 17:10:59 GMT 2012

Students drink beer during spring break in Florida.

Students drink beer during spring break in Florida. Photographer: Joe Raedle/Getty Images

H. Lundbeck A/S (LUN), the Nordic regions second-largest drugmaker, said its anti-alcoholism treatment nalmefene helped patients cut consumption by an average of 66 percent in three clinical trials.

Results of the final stage of clinical trials showed nalmefene helped curb drinking more than a placebo and medical advice, Lundbeck said in a presentation at a medical meeting in Prague today. Nalmefene users reported a 64 percent to 79 percent drop in total alcohol intake, compared with 49 percent to 64 percent for those on placebo, Copenhagen-based Lundbeck said.

Heavy drinking is Europes second-largest risk factor for poor health. Lundbeck plans to offer nalmefene as a treatment option to those who suffer from alcohol dependency and are turned off by abstinence, which is advocated by most experts, said Anders Gersel Pedersen, head of Lundbecks research and development. About 70 percent of patients who enrolled in the clinical trials for nalmefene had never received treatment, Pedersen said in a telephone interview.

It changes the whole paradigm around the conversation about alcohol use between the physician and the patient, he said.

Lundbeck submitted nalmefene, which may become the first new medicine sold to treat heavy drinking in more than 15 years, to the European Medicines Agency in December based on the research. A decision on the drug from the European regulator probably will come in the beginning of next year, Pedersen said.

Lundbeck fell 0.7 percent to 117.10 kroner in Copenhagen. Shares of Turku, Finland-based Biotie Therapies Oyj (BTH1V), which licensed nalmefene to Lundbeck, rose 2 percent to 52 euro cents in Helsinki. If the product is cleared, Biotie may receive as much as 84 million euros ($111 million) in payments from Lundbeck in addition to royalties on sales.

Patients taking nalmefene had high withdrawal rate in one of the three late-stage studies, mostly because of adverse events, Danske Markets analysts attending the Prague meeting wrote today in a note to investors. In the six-month Esense 1 trial, only 142 of 302 patients on the drug completed the study, compared with 205 of 296 patients taking placebo, the analysts said. The most frequent adverse events were dizziness, insomnia and nausea, Lundbeck said.

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Lundbeck Anti-Binge Drinking Drug Helps Cut Intake 66% in Clinical Trials