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Flexible Dosing of Pregabalin Offers Significant Seizure Reduction With Favorable Safety Profile

-- Confirms findings seen in three fixed-dose trials --

SAN FRANCISCO, CA -- May 3, 2004 -- A new study presented at the American Academy of Neurology (AAN) 56^th Annual Meeting demonstrated the efficacy and safety of pregabalin as an adjunctive epilepsy therapy when administered as a flexible dose in patients with partial seizures.

"This study is the first to report flexible dosing of pregabalin, which is closer to real-world experience and may allow physicians to optimize seizure reduction and safety for individual patients," said Dr. Alan Guberman, professor and head, division of neurology, The Ottawa Hospital, Ottawa, Canada.

The study was designed to determine the effects of flexible dose pregabalin on efficacy and safety. It was a double-blind, placebo-controlled, multicenter study which included 51 centers and 341 patients with refractory epilepsy receiving at least one but no more than three antiepileptic drugs. Two or three antiepileptic drugs were already being taken by 75 percent of the study participants at baseline and the median number of seizures at the start of the study was nine. Pregabalin provided a clinically significant reduction in seizures, regardless of whether the dosing schedule was fixed (600 mg/day) or flexible (increasing dose from 150 mg/day to 600 mg/day) over time. Seizure reduction was significantly greater in patients treated with pregabalin fixed dose (49.3 percent) and pregabalin flexible dose (35.4 percent) compared with placebo (10.6 percent). The number of patients who had a 50 percent or greater reduction in seizures also was significantly improved for those treated with pregabalin fixed dose (45.3 percent) and flexible dose (31.3 percent) compared with placebo (11.0 percent).

The most common adverse events reported were mild to moderate in intensity, and included dizziness, ataxia, weight gain, asthenia, somnolence, vertigo and double and blurred vision.1 (line 51)

The efficacy and safety of pregabalin has been tested in more than 10,000 patients.2 (pp29) Pregabalin is currently under review by the U.S. Food and Drug Administration.1 (lines 1-3) for the management of neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (post-herpetic neuralgia), as adjunctive therapy in the treatment of partial seizures, and for the treatment of generalized anxiety disorder in adults.

Epilepsy, a chronic neurologic condition that is characterized by seizures, affects an estimated 50 million people worldwide, with 2.5 million people affected in the United States alone. Although the cause of epilepsy is uncertain, it can be associated with neurologic disorders including head injuries, tumors and stroke. Current treatment options focus on preventing or decreasing the frequency of seizures.

SOURCE: Pfizer Inc

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