Drug News: Oxtellar XR Approved as Monotherapy

The U.S. Food and Drug Administration (FDA) has approved the use of Oxtellar XR (the extended release form of the compound oxcarbazepine) as a monotherapy or stand-alone treatment for partial-onset (focal-onset) seizures in people aged 6 years and older.

The FDA’s approval is based on evaluating its use as an adjunctive (add-on) therapy for partial-onset seizures in adults. Its use in children was based on well-controlled studies in adults, clinical trials of immediate-release oxcarbazepine in children, and looking at how it is absorbed, travels through, and metabolized by a child’s body.

Supernus, makers of Oxtellar XR, plan to make the monotherapy treatment available in the first quarter of 2019. It will come in 150mg, 300mg, and 600mg extended-release tablets in 100-count bottles.

What does this mean for me?

• If you are taking Oxtellar XR as an add-on medication, talk with your epilepsy care team before making any changes to your treatment plan.
• If you have focal-onset seizures and they are not fully controlled, talk with your epilepsy care team about whether this is a treatment option for you.
• If it is difficult for you to take your medications on schedule or if your seizures follow a pattern during the day, talk with your epilepsy team about whether an extended release medication is an option for you.

Learn More about Anti-Seizure Medications

• How Medicines Work
• Importance of Taking Medication on Schedule
• Common Concerns