UCB Receives FDA Orphan Drug Designation for Brivaracetam for the Treatment of Symptomatic Myoclonus
UCB announced that the Office of Orphan Products Development of the U.S. food and Drug Administration (FDA) has granted Orphan Drug Designation to brivaracetam for the treatment of symptomatic myoclonus.
Earlier this year, in August 2005, the European Commission granted orphan medicinal designation to brivaracetam for the treatment of progressive myoclonic epilepsies. UCB plans to accelerate development efforts and will work closely with the regulatory agencies in protocol designs.
Brivaracetam, a SV2A ligand that is differentiated from levetiracetam (Keppra®) by its mechanism of action profile has shown a significant antiepileptic activity in experimental models of epilepsy and myoclonus, as well as in a photosensitive epilepsy model in humans. Brivaracetam is currently being studied (Phase 2 clinical trials) in patients with refractory partial onset seizures and in patients with post-herpetic neuralgia.
Myoclonus is defined as sudden, brief, shock-like involuntary movements affecting one or more muscles. It can be a symptom of manifold diseases of varying underlying aetiologies, including different epileptic syndromes.
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