Baclofen is an antispasmodic agent that induces muscle relaxation. It is mainly used to treat skeletal muscle spasticity and other types of severe muscle spasms, usually caused by multiple sclerosis and spinal cord injuries. The drug was initially intended to treat epilepsy; however, the results of the clinical trial were disappointing, and the drug was introduced to the market fifteen years later in 1977 as a treatment for muscle spasticity.
Baclofen is known for its off-label uses, most commonly its use as a treatment for alcohol use disorder (AUD). The matter of baclofen's efficiency in treating this disorder is quite unsettled. The clinical trials regarding the drugs usage as a treatment for AUD came back inconclusive; whereas the way baclofen works is still a mystery, moreover, the trials did not come up with any data to show that baclofen does or does not treat AUD. This uncertainty was enough for the FDA to disapprove of the drug's usage for anything other than muscle relaxation. However, the French drug agency (ANSM) decided to acknowledge the drug as a treatment for AUD, in condition that the patient be in high risk of failure of usage of other medicinal treatments and when the reduction of alcohol consumption be essential. The drug is to be reevaluated every 3 years and is then resubmitted to the French market.
Over 60,000 patients are currently treated with baclofen in France for AUD, most of whom at doses lower than 80 mg per day.
Total reimbursed Baclofen MOH 2021 was over 11 million USD.
Baclofen reimbursed France consumption data:
Sample France Baclofen pricing data:
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