OVATION Pharmaceuticals, Inc. announces the expansion of its central nervous system (CNS) development pipeline with the initiation of a pivotal clinical trial to support a new drug application of intravenous (IV) carbamazepine in adult patients with epilepsy. Epilepsy affects approximately 2.7 million people in the United States. To date, there have been no intravenous options for patients that are therapeutically equivalent to oral carbamazepine when replacement therapy is required.
IV carbamazepine is a novel formulation of the widely used oral antiepileptic drug (AED) carbamazepine. As the first and only injectable form of the drug, IV carbamazepine is an important alternative for patients with epilepsy who may be hospitalized or otherwise temporarily unable to take oral carbamazepine. This clinical trial is designed to evaluate the bioequivalence of the intravenous doses with oral doses as well as assess the safety, tolerability and pharmacokinetics of IV carbamazepine relative to orally administered carbamazepine.
“Epilepsy is a devastating illness for patients and their caregivers,” said Jeffrey S. Aronin, President and Chief Executive Officer of OVATION. “This trial reinforces our commitment to introducing new epilepsy treatment options, particularly where current treatment needs are not fully addressed. This product represents one of five CNS launches OVATION expects over the next five years from our CNS pipeline.”
Fifteen investigative sites around the United States have begun recruiting patients with epilepsy who are currently on stable doses of oral carbamazepine. The sequential, open-label, 65-day study has already accepted more than 40 patients and plans to enroll 96 patients in total.
“For years, neurologists have been asking for an intravenous formulation of oral carbamazepine, which has been a mainstay treatment for patients with partial seizures,” according to Stephen Collins, M.D., Ph.D., Chief Scientific Officer and Vice President of Clinical Affairs.
“For those times when patients require an IV form of the drug, physicians prefer to use the IV formulation of the patient’s current oral AED therapy instead of switching to a new antiepileptic agent because it provides equivalent therapeutic levels and easy conversion back to the oral formulation. Until now, no one has been able to make a soluble version of oral carbamazepine.” The early proof-of-concept studies for the product were conducted by Drs. Jim Cloyd, Ilo Leppik and Angela Birnbaum at the University of Minnesota College of Pharmacy.
IV carbamazepine is part of OVATION’s robust CNS development program. The company is advancing its near-term pipeline on other fronts as well with its novel treatment for a catastrophic childhood epilepsy that will soon begin enrollment in a pivotal Phase III clinical trial and the anticipated launch next year of another oral anticonvulsant for rare and refractory epilepsies.
Patients with epilepsy may require switching from oral to an IV formulation of carbamazepine during times when oral administration is not feasible including prior to and after surgery, for use when patients become unstable during hospitalization or during hospitalization when oral therapy may not be appropriate. IV carbamazepine is unique from other IV anticonvulsants because it is the same active molecule -- carbamazepine -- and, unlike some other IV anticonvulsants, the formulation does not require refrigeration and should enable rapid infusion.
About Carbamazepine
Carbamazepine as an oral preparation has a well-established therapeutic profile with nearly 40 years of clinical use in the United States and around the world. It is used in the management of complex partial seizures, as an adjunct in some patients with secondary or partial epilepsy (epilepsy originating in one area of the brain) with complex symptomatology or secondarily generalized seizures (partial seizures followed by epileptic activity in the entire brain) when administered in combination with other antiepileptic drugs (AEDs). It has also been found useful as an alternative medication in patients with generalized tonic-clonic seizures (the most common type of generalized seizures) who are experiencing marked side effects or fail to respond to other anticonvulsants.
Products that contain carbamazepine have been associated with rare but serious types of blood disorders. Dizziness, drowsiness, unsteadiness, nausea, and vomiting are the most frequently observed adverse reactions, particularly during the initial phase of therapy.
About Epilepsy
According to the Epilepsy Foundation, there are approximately 2.7 million adults with epilepsy in the United States, making it the third most common neurological disorder in adults after Alzheimer’s disease and stroke. Epilepsy is a neurological condition affecting the nervous system that produces seizures—which are sudden surges of electrical activity in the brain that usually affect how a person feels or acts. Some seizures can hardly be noticed, while others are totally disabling. The seizures in epilepsy may be related to a brain injury or genetic tendency, but most of the time the cause is unknown.
About OVATION Pharmaceuticals
OVATION is a fast growing biopharmaceutical company that develops and commercializes medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients’ lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The five launches the company expects over the next five years will be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 “Pharma Company of the Year” award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at www.ovationpharma.com.