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May 9, 2007

Pfizer’s Lyrica: On Its way to An Approved Treatment for Fibromyalgia?

Analysis of: Pfizer’s Lyrica cuts fibromyalgia pain in study | www.reuters.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Louis Sanfilippo, MD, PresidentLouis Sanfilippo, MD
President, LCS Group, LLC
Implications:

While fibromyalgia is not well understood and sometimes conceived of as having psychosomatic contributions, it is estimated to affect up to 2% of the population and still has no FDA approved medication treatments for it.

Previous data on pregabalin (Lyrica; from Pfizer), a novel alpha-2 ligand, suggests it may help reduce pain and fatigue and improve sleep associated with fibromyalgia (in a 2005 randomized controlled trial). Lyrica is approved for treatment of diabetic peripheral neuropathy, post-herpetic neuralgia, and adjunctive treatment for partial onset seizures.

 



Analysis: Treatment of fibromyalgia treatment could represent a very large market. Present treatments are off-label and in the form of analgesics, antidepressants, muscle relaxants, and anticonvulsants. Eli Lilly’s Cymbalta has marketed toward the ‘physical’ symptoms of depression – not fibromyalgia itself but likely a subset this broadly conceived condition which is often characterized by mood and anxiety symptoms. Lilly is expected to file an supplemental NDA for fibromyalgia in the coming months based on positive data for the condition.

My own experience with Lyrica is that it offers some benefit as an off-label treatment of anxiety, and its non-SSRI and non-benzodiazepine mechanism of action gives it some added appeal. Should it receive a fibromyalgia indication, I think its off-label use for anxiety and other psychosomatic conditions would increase as well.

Lyrica is approved for the treatment for Generalized Anxiety Disorder in Europe and despite controlled data demonstrating its potential efficacy for the disorder, it was denied FDA approval for the condition in 2004.



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