An action letter is anticipated before the end of 2014. Carbella is the proposed US trade name for intravenous carbamazepine.
Oral carbamazepine is an important treatment option for people with epilepsy. Intravenous carbamazepine received orphan drug designation from the FDA in 2013 and is proposed for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types, when oral carbamazepine administration is temporarily not feasible.
Lundbeck US drug development vice president and chief medical officer Torsten Meldgaard Madsen noted the company has a long-term commitment to helping people with epilepsy, and today is an important milestone toward helping those who may need other options for receiving carbamazepine.
"We are proud of our portfolio of therapies for people living with epilepsy, and we hope to be able to provide intravenous carbamazepine as another important treatment option," Madsen added.