Belgium’s UCB says that it has filed lacosamide, its new drug to treat diabetic neuropathic pain, with the European regulatory authorities.
The company noted that an application for marketing authorisation has been made for the drug, which will be sold as Vimpat, by its subsidiary Schwarz Pharma to the European Medicines Agency. The filing is on schedule and an application to the US regulatory authorities is forecast to be submitted in the fourth quarter of 2007, Iris Loew-Firedrich, UCB's global head of development, said.
Lacosamide is an anticonvulsant of a new generation with a novel dual mode of action acting on collapsing response mediator protein 2 and sodium channel slow inactivation. UCB said that it has not shown clinically relevant interactions with other antiepileptic drugs, oral contraceptives or food, neither have oedema or weight gain been reported during trials. Dizziness and nausea were the most commonly reported side effects whereas somnolence was notably low.
Schwarz believes that lacosamide has great potential, which is welcome news for UCB as it is facing the loss of patent protection on key products such as the antihistamine Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam). An application for marketing approval for Vimpat as a therapy for adult patients with epilepsy with partial onset seizures was accepted for review by the European authorities in May and proof-of- concept studies in additional indications such as fibromyalgia, osteoarthritis and migraine prophylaxis have already been initiated. First results from this studies are scheduled for next year.