A new treatment to manage the chronic pain experienced by more than 40% of spinal cord injury patients is being made available in the USA after being given a green light from the country's drug regulator.
Pfizer's Lyrica (pregabalin) becomes the first ever medication to be approved for managing neuropathic pain associated with spinal cord injury - pain that can be experienced above or below the level of the injury, with around one-third of the 270,000 US patients describing it as severe or excruciating.
The approval was based on two randomised Phase III trials involving 357 patients, which found that Lyrica significantly reduced neuropathic pain compared to placebo (against a background of continued usual pain medication, including opioids and NSAIDs). In addition, more patients in the Lyrica group showed a 30% or 50% reduction in pain versus placebo receivers.
Lyrica is Pfizer's second biggest selling drug after its once-$13 billion earner, the cholesterol-lowerer Lipitor (atorvastatin), which lost patent protection in November last year. It is already approved in the USA for diabetic nerve pain, pain after shingles, fibromyalgia and partial onset seizures in epilepsy, and brought in sales just shy of $1 billion for the first quarter of this year.