In a 6-month pivotal study, LYRICA (pregabalin) provided sustained relief of Fibromyalgia pain

Adapted from Crofford et al. Pain. 2008.1 and Pfizer data on file.2b

Results from a multicenter, 26-week, double-blind, placebo-controlled, randomized discontinuation trial of 1051 patients. The study was composed of 4 phases: baseline (1 week), open-label treatment (6 weeks), double-blind treatment (26 weeks), and follow-up (1 week). During the 6-week open-label phase, LYRICA dosage was adjusted to 300 mg/day, 450 mg/day, or 600 mg/day to optimize pain control and tolerability. Of the 663 (63%) patients completing the open-label phase, 566 (85%) were considered responders, defined as patients who had 50% reduction in pain and PGIC scores “much improved” or “very much improved,” and randomized to double-blind treatment.

The primary efficacy measure was the time to loss of therapeutic response (LTR), defined as <30% reduction in pain compared to open-label baseline, or worsening of symptoms necessitating an alternate treatment. Patients who did not complete the study due to adverse reactions were considered as having lost therapeutic response. Patients were not permitted to use other Fibromyalgia treatments or agents that treat pain. Acetaminophen 4 g/day was allowed as a rescue medication.2b

Analyses of secondary endpoints compared time to worsening of these endpoints between LYRICA and placebo. The Fibromyalgia Impact Questionnaire (FIQ) measured aspects of pain, symptoms of disturbed mood, and function. The FIQ is a 20-item validated self-assessment tool used to measure the impact of symptoms and track the progress of symptoms over the previous week; score range is 0 to 100, with 0 indicating no impact.

Patient Global Impression of Change (PGIC) was evaluated as a secondary efficacy measure at the completion visit, and was measured by patient self-evaluation on a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

In a 6-month pivotal study, Function improvement was maintained for a significantly longer period of time vs placebo, as measured by FIQ2d*

Pain Reduction Graphic

References:

1. Crofford LJ, Mease PJ, Simpson SL, et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain. 2008;136(3):419-431.

2a. Data on file. Modified BOCF LTR analysis (fibromyalgia study A0081059). Pfizer Inc, New York, NY.

2b. Data on file. LYRICA Summary Basis of Approval. June 21, 2007. Pfizer Inc, New York, NY.

2c. Data on file. PGIC analysis. (fibromyalgia study A0081059). Pfizer Inc, New York, NY.

2d. Data on file. Modified BOCF function analysis (fibromyalgia study A0081059). Pfizer Inc, New York, NY.

3. Pauer L, Akinson G, Murphy TK, Petersel D, Zeiher B. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012;28(7):609-614.