Lundbeck announced that the FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain 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 (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

Carnexiv is a short-term (≤7 days) intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and have the following seizure types:

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

As with the oral carbamazepine formulation, there is a risk of serious dermatologic reactions during treatment with Carnexiv, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), as well as a risk of aplastic anemia and agranulocytosis.

“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,” said Peter Anastasiou, president, Lundbeck North America. “As part of Lundbeck’s ongoing commitment to the epilepsy community, we are proud to offer Carnexiv to help meet the need for continuity of care for these patients.”

Partial seizures and generalized tonic-clonic seizures can often be difficult to control. As a result, many patients with epilepsy are on a daily regimen of one or more AEDs that has been carefully adjusted to obtain a therapeutic response. Switching or an abrupt discontinuation of AEDs can lead to seizure recurrence or breakthrough seizures.

Researchers at the University of Minnesota College of Pharmacy helped conduct early clinical proof-of-concept studies, which were instrumental in developing the formulation of Carnexiv, making intravenous administration possible. James Cloyd, PharmD, Angela Birnbaum, Ph.D., and Ilo E. Leppik, M.D., at the University of Minnesota partnered closely with Lundbeck during the clinical trial and approval process for Carnexiv.

“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,” said Cloyd, director of the Center for Orphan Drug Research at the University of Minnesota College of Pharmacy. “We’re proud to partner with Lundbeck and appreciate the company's dedication to overcoming development challenges and making this therapy option available for patients and clinicians.”