Pfizer's Lyrica (pregabalin) has been approved as the first drug for the management of fibromyalgia, FDA announced June 21.

"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," CDER Director Steven Galson said in a press release.

"However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder."

While the studies show that use of pregabalin can lead to decreased pain in fibromyalgia patients, "the mechanism by which Lyrica produces such an effect is unknown," FDA notes.

Lyrica, a Schedule V drug, is already approved for the management of postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy, indications FDA cleared in December 2004.

The sNDA was backed by a four-week double-blind, controlled clinical trial and a six-month randomized withdrawal study that included about 1,800 fibromyalgia patients receiving 300 mg, 450 mg or 600 mg of Lyrica per day.

Labeling recommends dosing of 300 mg to 450 mg per day; the agency notes the 600 mg dose did not confer additional benefits and was less well tolerated in the studies.

In the first study, based on the Patient Global Impression of Change (PGIC) scale, 77.8 percent of patients receiving Lyrica 450 mg reported "any improvement" in pain relief, versus 47.6 percent in the placebo group, according to the labeling. Of the patients receiving the 300 mg dose, 68.1 percent experienced an improvement and 66.1 percent of patients taking the 600 mg dose reported improved pain relief.

In the second trial, patients were titrated to a daily dose of 300 mg, 450 mg, or 600 mg during a six-week open-label dose optimization phase. Responders were randomized in a double-blind treatment phase with either their optimal Lyrica dose or placebo. Of the Lyrica patients, 53 percent remained on the drug and maintained a response until week 26 of the study, versus 33 percent on placebo.

Fibromyalgia is marked by prolonged or chronic pain, as well as muscle stiffness and tenderness and affects about 3 million to 6 million people in the U.S. each year, FDA says, noting the disorder mainly is seen in women and develops in early-to-middle adulthood.

Pfizer previously said it anticipates the fibromyalgia indication could produce $1 billion in incremental sales for Lyrica, which is also approved for use as an adjunctive therapy for partial onset seizures in adults with epilepsy.

As a condition of approval, Pfizer will conduct additional studies of the drug in children with fibromyalgia and in breastfeeding women.

Lilly intends to file an sNDA for its antidepressant Cymbalta (duloxetine) for treatment of fibromyalgia later this year (¹ Also see "Lilly’s Cymbalta Gets Generalized Anxiety Disorder Indication" - Pink Sheet, 26 February, 2007.).

In addition, Wyeth is studying its serotonin-norepinephrine reuptake inhibitor Pristiq (desvenlafaxine) in Phase III trials for the condition.

The Lyrica approval comes as positive news for Pfizer on the heels of receiving an "approvable" letter for maraviroc the day earlier (see ² Also see "Pfizer’s Maraviroc Deemed “Approvable” By FDA" - Pink Sheet, 21 June, 2007.).

-Brooke McManus (b.mcmanus@elsevier.com)

Pfizer’s Lyrica Is First Drug Approved For Fibromyalgia

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