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Pfizer’s Lyrica Fails to Outperform Placebo in Spinal Stenosis Study

Alex Constantine - December 22, 2014

Pfizer's Lyrica fails to outperform placebo in spinal stenosis study

By Douglas W. House

Seeking Alpha, December 11, 2014

  • In a small trial of 29 people with severe lumbar spinal stenosis, the most common cause of lower back pain, Pfizer's (NYSE:PFELyrica (pregabalin) did not perform any better than placebo in relieving pain.
  • Lyrica is not approved for the indication, but the company funded the study to explore the potential label expansion. In spinal stenosis, the canals where the nerves pass through the spine narrow due to conditions such as arthritis. The narrowed passages pinch the nerves causing chronic pain.
  • The product is currently approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adults with partial onset seizures, fibromyalgia and neuropathic pain associated with spinal cord injury.
  • Lyrica generated $4.9B in sales the past four quarters.


Pfizer’s Lyrica Doesn’t Help Most Common Back Pain, Study Finds

By Sonja Elmquist

Bloomberg News, Dec 11, 2014 (Excerpt)

spinal stenosis symptoms2 - Pfizer's Lyrica Fails to Outperform Placebo in Spinal Stenosis Study... In a trial of 29 people over the age of 50 with severe lumbar spinal stenosis, those given Lyrica saw no more improvement than with a placebo, according to research published yesterday in the journal Neurology. Lyrica, also known as pregabalin, is already used to treat pain caused by shingles and diabetes and for conditions including epilepsy, fibromyalgia and hot flashes.

Sales of Lyrica reached $4.6 billion last year, accounting for 9 percent of Pfizer’s total revenue. ...

“The core issue is we’re still looking for effective therapies for nerve pain that comes from the spine,” said John Markman, the doctor who led the study. “That is by far the most common reason folks seek care for pain.”

... Lyrica has become increasingly important to Pfizer’s earnings since the New York-based company lost patent protection on its cholesterol pill Lipitor, which once generated almost $13 billion a year. In February, Pfizer won a court ruling that will block generic versions of Lyrica until December 2018.

The drug’s reputation may be strong enough to withstand the results of the trial, said Houman Danesh, a specialist in pain management, rehabilitation and physical medicine at New York’s Mount Sinai Hospital. ...