Lundbeck's Carnexiv injection -- an orally administered replacement therapy for short-term use to treat adults with specific types of seizures -- has been approved by the U.S. Food and Drug Administration.
The FDA has previously granted Carnexiv Orphan Drug Designation due to the drug’s ability to treat seizures.
Carnexiv will be the first intravenous formulation made available that is an antiepileptic drug carbamazepine.
“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,” University of Minnesota College of Pharmacy’s Center of Orphan Drug Research Director James Cloyd said. “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.”
Lundbeck has plans to release Carnexiv commercially in the U.S. early next year.