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news.Pharmaceutical firm Lundbeck has secured approval from the US Food and Drug Administration (FDA) for Carnexiv (carbamazepine) injection as intravenous short-term replacement therapy for several seizure types.
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The injection has been approved as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not possible.
It is the first intravenous formulation of the anti-epileptic drug approved for sale in the US and it had orphan drug designation.
The commercial launch is expected to start in early 2017.
Carnexiv is a short-term replacement therapy, lasting for less than or equal to seven days, for oral carbamazepine for patients who find it difficult to take medication by mouth.
It is indicated for adults who are subject to partial seizures with complex symptomatology, generalized tonic-clonic seizures, mixed seizure patterns, or other partial or generalized seizures.
Lundbeck said when switching from oral carbamazepine, the entire daily dosage of Carnexiv should be 70% of the total daily dose of oral carbamazepine, divided equally into four separate 30-minute infusions separated by six hours.
After the completion of intravenous replacement period, patients should be switched back to their earlier oral carbamazepine total daily dose and frequency.
Lundbeck North America president Peter Anastasiou 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.
“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.”