Lundbeck epilepsy injection approved in US
Lundbeck’s epilepsy injection, Carnexiv has been approved in the US, the first time this drug has been available to patients when oral administration is not feasible.
The US Food and Drug Administration approved Carnexiv (carbamazepine) as a short-term replacement therapy for oral carbamazepine in adults with certain seizure types, when oral administration is temporarily not feasible.
Carnexiv has received orphan drug designation in this indication, and the company plans to launch the drug in the US in early 2017.
It is approved as a short term (less than seven day) replacement therapy for carbamazepine formulations for partial seizures with complex symptomatology, generalised tonic-clonic seizures and mixed seizure patterns including the above, or other partial or generalised 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.
Lundbeck said it is very difficult to make an aqueous-based injectable formulation of carbamazepine, and it has taken years of work to create this alternative form of the drug.
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, director of the Center for Orphan Drug Research at the University of Minnesota College of Pharmacy, 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.”
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 anaemia and agranulocytosis.
Last year the Danish pharma announced plans to cut 17% of its workforce to trim costs because of expired patents on antidepressant Cipralex (escitalopram) and Alzheimer’s drug Ebixa (memantine).
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