The Danish pharmaceuticals company Lundbeck is one step closer to releasing a pill that it claims is an effective treatment for alcoholism, after the drug passed phase III clinical trials with flying colours. While Lundbeck does not claim the ‘Nalmefene’ pill will completely eliminate the need to drink alcohol, the 12-month trials did result in a reduced consumption of more than 50 percent.
The phase III clinical studies monitored more than 2,000 individuals with a heavy alcohol dependency. It was the first time that approximately two-thirds of the participants had ever been treated for alcoholism.
In the first month of treatment the patients’ alcohol intake was shown to fall significantly, and over the course of the 12-month studies, researchers observed that the patients had significantly fewer “heavy drinking days” and overall alcohol consumption fell by more than 50 percent. Nalmefene was shown to diminish their desire to drink excessive amounts and, in particular, their taste for alcohol.
The pill showed few side effects at the prescribed, low dosage level and was also considered safe for the liver. Lundbeck claimed, moreover, that Nalmefene can be taken at will – on an “as-needed basis” – as a means to “limit the intake of alcohol, rather than requiring full abstinence”.
“Across the clinical phase III programme, consistency and robustness were observed and the studies support the overall positive clinical profile of Nalmefene,” announced Lundbeck’s director of development, Anders Gersel Pedersen, in a press statement.
“We are pleased that we now have reached a stage with Nalmefene where we can plan the regulatory process with an expected submission of the [EU marketing] application by the end of the year.”
The National Board of Health estimates that more than ten percent of the Danish adult population are alcoholics in need of some sort of alcohol treatment. It estimates moreover that 20 percent of the population drinks more than the recommended maximum alcohol intake –14 alcoholic units per week for women (the equivalent of 14 glasses of wine) and 21 alcoholic units per week for men (ten and a half pints of beer).
Nalmefene is also a potential treatment for addictions to all types of opioid drugs – including morphine, codeine and opium – as well as a treatment for addictive behaviours.
An early clinical study of Nalmefene’s effect on compulsive gamblers, which was reported in the American Journal of Psychiatry in 2006, reported that 59.2 percent of patients on small doses of the drug showed “much improved”, or “very much improved”, behavioural control and significantly reduced their gambling, in contrast with 34 percent of the control group who received a placebo.
Lundbeck has big expectations for the drug.
“Nalmefene is a joker in our portfolio,” Lundberg’s president Ulf Wiinberg told Børsen financial daily last year, after Nalmefene had cleared phase II trials and phase III trials had just begun.
Wiinberg noted that the social costs of alcoholism alone were in the billions of euros, so potential sales could be as high as 2.5 billion kroner a year. He added, however, that real sales would depend on whether health authorities and the population at large could accept the idea of taking a pill to treat alcoholism or even heavy drinking.
Michael Friis Jørgensen, a senior analyst from Alm. Brand Markets, a Danish market research firm, suggested that the medical community itself could, in fact, be the biggest impediment to Nalmefene’s sales success – for the very reason that the pill helps alcoholics reduce their drinking to ‘safe’ levels without having to give up alcohol entirely.
Jørgensen told Berlingske newspaper that Lundbeck’s next challenge would be to convince doctors and alcohol treatment professionals that a Nalmefene pill and continued moderate drinking might be favourable to the current treatment philosophy of zero-tolerance or total abstinence.
