FDA accepts Lundbeck’s resubmitted application for IV form of anti-epileptic drug carbamazepine

The agency’s specific action date is not provided but is expected to happen before the end of this year.

Lundbeck received a complete response letter in October 2014 for its original application citing the need for additional chemistry, manufacturing and controls data.

Oral carbamazepine is considered as a key treatment option for people with epilepsy. Intravenous carbamazepine formulations are presently not available for patients who find it difficult to take the medication by mouth.

The FDA granted orphan drug designation to intravenous carbamazepine in 2013. It is proposed for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control several seizure types, when oral carbamazepine administration is temporarily not feasible.

Lundbeck chief medical officer of US drug development Daniele Bravi said: "As a company committed to helping people living with epilepsy, we have developed intravenous carbamazepine in the U.S. to address this unmet medical need.

"Intravenous carbamazepine could provide a valuable option for those who temporarily cannot take their oral carbamazepine."

Lundbeck employs about 1,000 people in the US, who are focused solely on accelerating therapies for brain disorders, including epilepsy.