Pfizer: Long-acting Lyrica better than placebo

Associated Press

TRENTON, N.J. (AP) — Drugmaker Pfizer Inc. said Monday that a late-stage patient study found an extended-release version of its pain drug Lyrica relieved pain better than a dummy pill in some patients, but the improvement didn't last much longer.

The study, funded by the New York-based drugmaker, is one of three late-stage patient tests aimed at gaining approval of Lyrica for another use, as a long-term daily pill to limit pain from fibromyalgia. That's a chronic condition, affecting more than 5 million Americans, involving bouts of widespread pain and tenderness.

A shorter-acting version of Lyrica, usually taken twice a day, is approved in about 120 countries for treating pain flare-ups from fibromyalgia, pain after shingles, nerve pain in diabetics, pain related to spinal cord injury and seizures in certain adults with epilepsy.

Pfizer gave 441 fibromyalgia patients either extended-release Lyrica or a dummy pill for six weeks. All of those who didn't have their pain cut by at least half were deleted from the study. The remaining 121 people received either extended-release Lyrica or a dummy pill for 12 more weeks, with no one knowing who received what. The study showed 54 percent of the Lyrica patients and 71 percent of the placebo patients, had much, if not all, of their original pain return. Lyrica stopped providing significant pain relief within 58 days, versus 22 days for patients getting dummy pills.

Lyrica sales have been growing steadily, hitting $1.04 billion in the third quarter. It's Pfizer's top-selling drug, since megablockbuster Lipitor for high cholesterol got generic competition last Nov. 30.

Possible side effects from Lyrica include dizziness, sleepiness, blurred vision, weight gain, increased appetite, trouble concentrating, rapid swelling of the skin's deeper layers, euphoric mood and balance disorder.

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