Lyrica pregabalin: Phase III data
Top-line data from a double-blind Phase III trial in epileptic patients with refractory partial onset seizures showed that Lyrica as adjunctive therapy met the primary endpoint of a "comparable proportion" of patients who achieved a >=50% reduction in 28-day seizure rate during the 12-week maintenance phase relative to levetiracetam. The most common adverse events reported in patients receiving Lyrica were headache, dizziness, insomnia, somnolence, nausea and fatigue. Patients received once-daily 300, 450 or 600 mg Lyrica or 1,000, 2,000 or 3,000 mg levetiracetam. The trial enrolled patients diagnosed with epilepsy with partial onset seizures for >=2 years and who were unresponsive to >=2 but <5 antiepileptic drugs and on stable doses of 1-2 standard antiepileptic drugs at the time of enrollment. Pfizer could not be reached for details, but said the data will be submitted for presentation at an upcoming medical meeting. ...