FDA Approves Lundbeck’s IV Carbamazepine For Certain Seizures

By James Radke, PhD at Rare Disease Report

The FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain rare seizure types when oral administration is temporarily not feasible.

Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug carbamazepine..

The company plans to have the drug available in early 2017.

Carnexiv is indicated to treat

• Partial seizures with complex symptomatology
• Generalized tonic-clonic seizures
• Mixed seizure patterns which include the above, or other partial or generalized seizures

In a press release, Peter Anastasiou, President, Lundbeck North America said:

“Carbamazepine has been an important treatment standard for people with epilepsy, but oral administration isn’t always possible, especially during hospitalizations or other circumstances where they are temporarily unable to take medication by mouth.”

Lundbeck acknowledged the important scientist work by researchers at the University of Minnesota College of Pharmacy to develop a liquid formulation, including James Cloyd, PharmD, Angela Birnbaum, PhD, and Ilo E. Leppik, MD.

Dr Cloyd, director of the Center for Orphan Drug Research at the University of Minnesota College of Pharmacy said:

“Carbamazepine is very difficult to make as an aqueous-based injectable formulation, which means that doctors have not had an IV formulation of the drug available when needed. This approval is the result of years of work to create a novel and stable injection formulation to support patients who need an alternative to oral carbamazepine.”

About Carnexiv (carbamazepine) injection

Carnexiv is a short-term (≤7 days) replacement therapy for oral carbamazepine for patients who are unable to take medication by mouth. When switching from oral carbamazepine, the total daily dosage of Carnexiv should be 70% of the total daily dose of oral carbamazepine, divided equally into 4 separate 30-minute infusions separated by 6 hours. At the end of the intravenous replacement period, patients should be switched back to their previous oral carbamazepine total daily dose and frequency as soon as clinically appropriate.