Sepracor sees FDA filing by late 2008, early 2009
Wednesday September 24, 4:38 pm ET
Sepracor expects to ask for epilepsy drug approval by the end of 2008 or early 2009
MARLBOROUGH, Mass. (AP) -- Sepracor Inc. said Wednesday it expects to ask the Food and Drug Administration for approval of an epilepsy drug candidate by the end of 2008 or early 2009.
The drug is licensed from Portugal-based Bial.
Sepracor said it is presenting data from three late-stage studies that show the once-daily drug significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy. The drug works in combination with other treatments.
The results are being presented at the 8th European Congress of Epileptology in Berlin.
"These data suggest that eslicarbazepine acetate has the potential to become an important treatment option for patients in North America whose seizures are not adequately controlled with existing anti-epileptic agents," said Dr. Mark H.N. Corrigan, executive vice president of research and development at Sepracor.
The company also plans to conduct studies on the drug as a stand-alone treatment and for potential use in children.
The drug candidate is already being reviewed by European regulators.
Shares of Sepracor fell 88 cents, or 5.2 percent, to close at $16.14. The stock earlier traded at a new 52-week low of $16.14. Shares have ranged between $16.46 and $30.60 over the past year.
surf's up......crikey
