By Melodie Warner
Pfizer Inc. (PFE) said a Phase 3 study showed its pregabalin controlled-release formulation as a potential epilepsy treatment didn't meet the primary endpoint for a change in seizure frequency.
Pregabalin CR, also known as Lyrica, is approved for five indications in the U.S., including four in the therapeutic area of pain.
Pfizer said the study evaluated 165-milligram and 330-milligram doses of pregabalin CR in adult epilepsy patients with partial-onset seizures.
Epilepsy is a chronic disorder in which seizures occur intermittently, and partial-onset seizures are the most common.
"While the study showed an observed improvement, it did not show a statistically significant difference in seizure frequency, which we believe may have been due to a higher-than-expected placebo response," said Steven J. Romano, senior vice president and head of the Global Primary Care Business Unit's medicines-development group.
This study was one of three Phase 3 pregabalin CR studies evaluating the drug's potential use as a once-a-day therapy. The other two studies are evaluating pregabalin CR in fibromyalgia and post-herpetic neuralgia. Pfizer said it will continue the other two studies.
Shares were trading eight cents lower at $23.58 premarket. The stock was up 9.3% this year through Thursday's close.
Write to Melodie Warner at melodie.warner@dowjones.com
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Pfizer: Lyrica Doesn't Meet Primary Endpoint in Study for Epilepsy