Drug producer Lundbeck has received European marketing approval for Selincro, a new drug to fight the disease of alcoholism, the firm said in a company release Feb. 28.
The company is the maker of the anti-depressant Lexapro, which is available in the United States. There was no indication from Lundbeck when the company will seek Food and Drug Administration (FDA) approval for the "revolutionary" treatment alternative in the U.S.
The European Medicines Agency (EMA) said on December 14 it recommended approval of the drug, in conjunction with counseling, for the reduction of alcohol consumption in adults. The European Commission approved that recommendation. Many of the 27 nations of the European Union (EU) are struggling with rising addiction and death rates from alcohol use disorders, and presently only eight percent of an estimated 14 million alcoholics receive any treatment. The company expects the drug to be available to patients through their physicians by mid-year.
Alcohol treatment is theoretically a vast market in both the U.S. and Europe, although it is unclear whether doctors will be ready to prescribe another drug as a treatment and whether Lundbeck has the marketing muscle to make a big impact. The drugs, acamprosate (marketing name: Campral) and naltrexone (ReVia) are presently available by prescription in the U.S. and were found to help those struggling in different phases of recovery. (See the related examiner.com article.)
Acamprosate helped manage emotional triggers in people who had already stopped drinking, naltrexone helped manage cravings in heavy drinkers who are trying to stop drinking or recently quit. The new pill is similar in that it blocks the action of opioid receptors – the motivation center – in the brain, however Lundbeck says it is okay to be taken in conjunction with active drinking and the company recommends it be taken as needed, one to two hours prior to a drinking episode.
For many patients with alcohol dependence, to entirely stop and abstain from drinking is not an acceptable or attainable treatment goal. Selincro will be the first medication specifically developed for the reduction of alcohol consumption in patients with alcohol dependence who maintain a high level of alcohol consumption. Selincro reduces alcohol consumption and thus the consequences of harmful drinking, and offers a new treatment option for patients who may not have sought treatment before.
“Selincro represents the first major innovation in the treatment of alcohol dependence in many years," said Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck. "The approval of Selincro is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment."
Lundbeck has its U.S. offices in suburban Chicago.