Aptiom, First medicine developed in Portugal, approved by the FDA for sale in the U.S.

November 11,2013 | By Márcio Barra

The first drug developed in Portugal, Eslicarbazepine acetate, from pharmaceutical BIAL, received on Friday approval from the U.S. Food and Drug Administration (FDA) for marketing in the United States.

Branded as Aptiom, the drug was approved as an add-on medication to reduce the frequency of partial seizures associated with epilepsy. The FDA based its approval primarily on three clinical trials, where Aptiom was shown to reduce the frequency of seizures in testing the drug against a placebo, while the ratings of depression and patients’ self-reported quality of life phases showed improvements over pre-treatment baseline during the extension. Participating subjects continued to use their previous anti-epileptic medications throughout the trials.