Depression and alcoholism sometimes go hand in hand. H. Lundbeck A/S (LUN) is counting on that connection to help it sell a new anti-binge-drinking pill.
At least 15 percent of those suffering from major depression are also alcohol dependent, according to academic research. Lundbeck thus plans to market the medicine to psychiatrists who treat patients suffering from both conditions, said Andreas Eggert, the executive in charge of commercializing the pill, called Selincro. Lundbeck, which last week won backing for Selincro from the European Union drug regulator, will draw on its expertise selling psychiatric treatments such as the anti-depressant Lexapro.
“There are a lot of similarities in the treatment of depression and the treatment of alcohol dependency,” Eggert said in a telephone interview. “We see a significant overlap with our existing sales force structure.”
Selincro, if approved, would be the first drug designed to treat alcohol abuse while allowing patients to continue drinking. Besides the EU, the company also plans to seek approval next year in Russia, where every fifth death results from alcohol abuse. Success for Selincro may shift the treatment of alcohol dependency away from abstinence, said David Nutt, a professor of neuropsychopharmacology at Imperial College London.
Lundbeck, based in Copenhagen, also will target general practitioners and alcohol-treatment centers. The European Medicines Agency recommended Dec. 14 that the European Commission grant Lundbeck approval to market the drug. The commission usually follows the agency’s recommendations.
While sales may reach 400 million kroner ($70 million) in 2016, success will depend on Lundbeck’s ability to work with governments in gaining reimbursement and publicly funded awareness campaigns, said Tim Race, a London-based analyst at Deutsche Bank, in a note to investors on Dec. 14.
Selincro, licensed from Turku, Finland-based Biotie Therapies Oyj (BTH1V), is designed to curb a person’s urge to have more than a few drinks in one sitting by blocking brain signals that make activities like drinking feel good.
In studies, patients were instructed to take one tablet one or two hours before the anticipated time of drinking. In one late-stage trial, monthly total alcohol consumption fell from 75 grams per day on average to 16 grams per day after one year of treatment, Lundbeck said. Mild side effects, such as insomnia and nausea, decreased over the course of treatment.
The pill, whose chemical name is nalmefene, offers an alternative to those who are unable to abstain from alcohol, which is the approach advocated by most experts, or are unwilling to try. More than two-thirds of patients who enrolled in the clinical trials for Selincro had never received treatment, the company has said.
“Many of these patients are already in the physician’s office” for depression, Eggert said. “But the dialogue is not happening because the only option available is abstinence.”
Because Lundbeck hasn’t conducted any trials studying the interaction between antidepressants and Selincro, it can’t recommend any combination treatment, he said. Instead, physicians may opt to take a sequential approach, which will require them to decide which condition to treat first.
Previous studies of patients taking antidepressants with approved drugs to treat alcohol dependence suggest the combination isn’t harmful, and may even be beneficial, said Imperial College London’s Nutt.
A University of Pennsylvania study published in the American Journal of Psychiatry in 2010 showed that Pfizer Inc. (PFE)’s Zoloft antidepressant combined with naltrexone, a generic drug, produced a 54 percent rate of alcohol abstention, compared with 21 percent and 28 percent, respectively, for the drugs taken on their own. The combination also produced fewer side effects than the single treatments.
Naltrexone differs from Selincro in that it is approved as a treatment to maintain abstinence, not to control consumption without quitting.
“I’d be very surprised if there were negative interactions” between Selincro and anti-depressants, said Nutt, former president of the British Association of Psychopharmacology. “It makes perfect sense to use an antidepressant workforce to market this drug; they’re both psychiatric diseases.” He has received grants or fees for consulting or speaking from drugmakers including Lundbeck, though he didn’t play a role in any research on Selincro.
Annual per capita alcohol consumption in Europe, at 12.18 liters (3.2 gallons), is double the global average and 40 percent higher than in the Americas, according to World Health Organization statistics.
Selincro hasn’t yet been filed in the U.S., where it would be protected from generic competition for only five years, compared with 10 years in Europe, according to the company. U.S. regulators also may have a preference for drugs that aid with abstinence over one that curbs binge drinking, said James Garbutt, medical director of the Alcohol and Substance Abuse Program at University of North Carolina at Chapel Hill.
While Alkermes Plc (ALKS)’s long-acting injectable version of naltrexone was studied to reduce heavy drinking, in the end, the Food and Drug Administration approved it only for abstinence maintenance, said Garbutt, lead author of the study published in 2005.
“That sends the message that they were hesitant to approve a drug based on reduction of heavy drinking,” said Garbutt, who no longer consults for Alkermes and doesn’t consult for Lundbeck.
Unlike with naltrexone, patients would take Selincro as needed, instead of on a steady regimen.
“We like the concept that the patient is in charge,” Lundbeck Chief Executive Officer Ulf Wiinberg said in an interview this month.
Once the drug has been introduced in Europe and doctors and patients gain experience using it, Lundbeck may open up discussions with regulators in other countries such as the U.S., Japan, South Korea, and China, Wiinberg said.
“Our focus is now on Europe and getting Europe fixed first,” he said.
Alcohol abuse results in 2.5 million deaths each year, more than those caused by AIDS or tuberculosis, according to the Geneva-based WHO. Globally, the highest proportion of alcohol- related mortality is in Russia and neighboring countries.
Lundbeck plans to submit Selincro to Russian regulators in the first half of 2013, Eggert said. Russia is aiming to almost halve per capita annual consumption of alcohol to 8 liters by 2020, the level accepted by the WHO.
While there is a significant unmet need for a drug like Selincro in Russia, sales may depend on the price because many medicines in the country have a large out-of-pocket component that consumers have to pay, said Michael Kleinrock, director of research development at the IMS Institute in Plymouth Meeting, Pennsylvania.
“If the payer doesn’t carry a large amount of the cost, then it’s down to whether the patient can afford it,” Kleinrock said.
Other alcoholism therapies include the generic drug disulfiram and Forest Laboratories Inc.’s (FRX) Campral, used to help patients who have abstained. Disulfiram causes illness when alcohol is consumed, while Campral eases symptoms of withdrawal such as anxiety and insomnia.
Success of Selincro may vary by country, as doctors in some still don’t believe in medical treatment for addictions, though they are becoming a minority, Nutt said. The U.K. and Sweden prefer abstinence, while France, Italy and Germany are more interested in drug treatments, he said.
Drugs aren’t always the best or only form of treatment for mental disorders, which can include behavioral therapy, said Seena Fazel, senior lecturer at the University of Oxford’s department of psychiatry.
“There are disorder-specific issues and psychiatrists don’t just use medication,” Fazel said. Still, “the body of evidence supporting medication is accumulating.”
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