When a new drug is approved and enters the marketplace, often the only safety and efficacy information available is based on a few thousand people who took the drug during strictly controlled clinical trials. Not surprisingly, these trials are designed to focus on the drugs’ benefits, and may not include a large enough sample size to elicit serious adverse effects. Once the drug is available for widespread use, we are able to better evaluate the real safety profile of the drug. Read more →

In October, the Federal Drug Administration approved lacosamide as add-on therapy for adults with partial seizures. The approval is based on data from multiple phase 1, 2, and 3 clinical trials involving approximately 1300 people.

The study participants were aged 16 years or older, and experienced between 10 and 17 seizures per month. Patients continued to take 1 to 3 previously prescribed antiepileptic drugs (AEDs) while taking lacosamide in the study. Nearly half of the study participants had tried 7 or more AEDs, and still experienced a lack of seizure control. Read more →