FDA Approves Carnexiv
FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types
DEERFIELD, Ill.--(BUSINESS WIRE) October 07, 2016 --Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.
Carnexiv is a short-term (≤7 days) intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and have the following seizure types:
- Partial seizures with complex symptomatology
- Generalized tonic-clonic seizures
- Mixed seizure patterns which include the above, or other partial or generalized 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.
“Carbamazepine has been an important treatment standard for people with epilepsy,1 but oral administration isn’t always possible, especially during hospitalizations or other circumstances where they are temporarily unable to take medication by mouth,” said Peter Anastasiou, President, Lundbeck North America. “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.”
Partial seizures and generalized tonic-clonic seizures can often be difficult to control.2 As a result, many patients with epilepsy are on a daily regimen of one or more AEDs that has been carefully adjusted to obtain a therapeutic response. Switching or an abrupt discontinuation of AEDs can lead to seizure recurrence or breakthrough seizures.3,4
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, PharmD, Angela Birnbaum, PhD, and Ilo E. Leppik, MD at the University of Minnesota partnered closely with Lundbeck during the clinical trial and approval process for Carnexiv.
“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,” said Cloyd, director of the Center for Orphan Drug Research at the University of Minnesota College of Pharmacy. “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.”
About Carnexiv (carbamazepine) injection
Carnexiv is an intravenous antiepileptic drug developed in the United States by Lundbeck and approved for use in the United States. Carnexiv is a short-term (≤7 days) replacement therapy for oral carbamazepine for patients who are unable to take medication by mouth. When switching from oral carbamazepine, the total daily dosage of Carnexiv should be 70 percent of the total daily dose of oral carbamazepine, divided equally into four separate 30-minute infusions separated by 6 hours. At the end of the intravenous replacement period, patients should be switched back to their previous oral carbamazepine total daily dose and frequency as soon as clinically appropriate.
Lundbeck is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of research focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders - we call this Progress in Mind.
Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. We have research centers in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion).
In the U.S., Lundbeck employs nearly 1,000 people focused solely on accelerating therapies for brain disorders, including epilepsy. With a special commitment to the lives of patients, families and caregivers, Lundbeck U.S. actively engages in hundreds of initiatives each year that support our patient communities.
- Glauser T, Ben-Menachem E, et al. ILAE Treatment Guidelines: Evidence-based Analysis of Antiepileptic Drug Efficacy and Effectiveness as Initial Monotherapy for Epileptic Seizures and Syndromes. Epilepsia. 2006. 47(7):1094-1120.
- Mattson R, Cramer J, et al. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. N Engl J Med. 1992. 327(11):765-71.
- Finamore JM, Sperling MR, et al. Seizure outcome after switching antiepileptic drugs: A matched, prospective study. Epilepsia. 2016:57(8):1294-300.
- Wang SP, Mintzer ST, et al. Seizure recurrence and remission after switching antiepileptic drugs. Epilepsia. 2013. 54:187-193.
Posted: October 2016
- FDA Accepts Lundbeck Resubmission of New Drug Application for Carnexiv (carbamazepine) - April 22, 2016