The European Medicines Agency’s (EMA) Committee for Medicinal Productiosn for Human Use (CHMP) has recommended the approval of Lundbecks’s Selincro for the reduction of alcohol consumption.
The Committee recommended that Selincro (nalmefene) be used alongside continuous psychosocial support, focusing on treatment adherence and alcohol consumption reduction.
Selincro has been developed to help reduce alcohol consumption in adults who maintain a high level of alcohol consumption (males consuming more than 60g of alcohol a day; females consuming more than 40g of alcohol a day), providing they do not have physical withdrawal symptoms and do not require immediate detoxification.
The drug contains nalmefene, which is an opioid system modulator that works on the brain’s motivational system and is understood to reduce the reinforcing effects of alcohol.
“Selincro represents the first major innovation in the treatment of alcohol dependence in many years,” said Anders Gersel Pedersen, executive vice president and head of research and development at Lundbeck.
“The Committee’s support of Selincro brings us closer to encouraging more patients with alcohol dependence to potentially seek help and treatment.”
The CHMP opinion was based on the results from three randomised, double blind, placebo controlled clinical trials, which studied the effects of Selincro on adult patients with alcohol dependence.
The study involved approximately 2,000 patients diagnosed with alcohol dependency, two-thirds of whom has not previously received treatment for the condition.
Patients treated with Selincro demonstrated a more than 40 per cent reduction of alcohol consumption within the first month and more than 60 per cent at the end of the study (6 or 12 months).