New dosage strengths of Zonegran provide flexible dosing options in seizure control
DUBLIN, IRELAND, August 29, 2003 -- Elan Corporation announced that it has received approval from the FDA to market two new lower dosage strengths, 25 mg and 50 mg, of Zonegran (zonisamide) in addition to the original 100 mg capsule.
Zonegran is indicated as adjunctive therapy for the treatment of partial seizures in adults with epilepsy. Elan expects to launch the new dosage strengths in the fourth quarter of 2003.
"The FDA approval of the 25 mg and 50 mg doses of Zonegran enhances the position of Zonegran in the epilepsy market," said Lars Ekman, MD, PhD, Executive Vice President and President, Research and Development at Elan. "With the availability of 25 mg and 50 mg strengths, physicians now have the benefit of more flexible dosing options to better manage patients and achieve effective seizure control."
Epilepsy is estimated to affect over two million people in the United States. There is no known cure for epilepsy, but medication, including antiepileptic drugs ("AEDs") such as Zonegran, controls seizures in many people. Zonegran is well tolerated and the side effects are generally mild to moderate and dose related. The most common side effects associated with Zonegran include somnolence (sleepiness), dizziness, anorexia, headache, nausea and agitation/irritability. Few drug-to-drug interactions are likely with Zonegran.
For complete prescribing information, visit www.elan.com
Posted: August 2003