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news.The world's largest pharmaceutical company Pfizer has received FDA approval to market Lyrica for adjunctive treatment of partial onset seizures in adults with epilepsy. The designation now means that Lyrica is approved for neuropathic pain and epilepsy in 47 countries.
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The efficacy of Lyrica was established in three double-blind, controlled trials involving 1,052 patients. At the start of treatment with Lyrica, patients experienced approximately ten seizures a month despite taking one to three other antiepileptic medications. Patients receiving adjunctive treatment with Lyrica experienced a reduction in the frequency of partial seizures by up to 51%. Lyrica can be given to patients two times or three times a day.
“There is a significant need for new antiepileptic drugs, as no new agent has been introduced in five years,” said Dr Jacqueline French, Professor of Neurology, University of Pennsylvania Medical School.
“Poor seizure control in patients with epilepsy has emotional and functional consequences that can significantly diminish quality of life. In clinical trials, Lyrica significantly reduced the frequency of seizures in patients who continue to experience seizures despite their standard treatment with antiepileptic medicines.”
The FDA approved Lyrica in December 2004 for the management of diabetic peripheral neuropathy and postherpetic neuralgia. Lyrica is an alpha-2-delta ligand with a newly defined mechanism of action that is believed to work by calming hyper-excited neurons.