By Pat Anson, Editor
Lyrica was originally marketed as an anti-seizure medication for epilepsy, although that’s never stopped Pfizer from looking for new ways to have doctors prescribe its blockbuster drug -- for everything from anxiety to shingles to fibromyalgia.
But efforts to get Lyrica approved as a treatment for post-traumatic nerve pain appear to have reached a dead end. Pfizer says a Phase III clinical study found that pregabalin – the generic name for Lyrica – worked no better than a placebo in controlling chronic nerve pain caused by traumatic accidents or surgery.
“The study did not meet its primary efficacy endpoint,” Pfizer said in a brief statement about its 15-week, double-blind, placebo-controlled study
There is no treatment currently approved by the Food and Drug Administration for post-traumatic neuropathic pain.
Lyrica is currently approved for use in over 130 countries. The FDA has approved Lyrica to treat chronic nerve pain caused by diabetes, fibromyalgia, epilepsy, spinal cord injury and post-herpetic neuralgia caused by shingles. The drug is also prescribed “off label” to treat a variety of other conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.
According to ClinicalTrials.gov, dozens of new studies are underway to test the effectiveness of pregabalin on conditions such as muscle cramps, coughs, irritable bowel syndrome, scoliosis, addiction, and phantom limb pain.
Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion. Earlier this year, the company agreed to pay $400 million to settle a shareholder lawsuit over allegations it marketed Lyrica and several other drugs off-label. The lawsuit stemmed from a $2.3 billion settlement with the federal government in 2009 for fraudulent marketing and illegal kickbacks paid to doctors who prescribed Lyrica and other Pfizer products.
Common side effects of Lyrica are dizziness, blurred vision, nausea, headache, weight gain and fatigue. Pfizer says Lyrica may also cause suicidal thoughts in about 1 in 500 patients who use it. The company also advises patients not stop taking Lyrica without talking to their doctor. Suddenly stopping the medication may result in withdrawal symptoms such as headaches, nausea, diarrhea, trouble sleeping, increased sweating, and anxiety.
Pfizer Expands Financial Aid to Patients
Pfizer recently announced it was expanding its financial assistance to patients by doubling the allowable income level for people to receive medications without a copayment.
Under Pfizer's RxPathways program, the company will cover copayments for Lyrica and 43 other medicines for both uninsured and underinsured patients earning up to four times the federal poverty level. The new limits are $47,080 annually for a single person and $97,000 for a family of four.
The RxPathways program helped about 350,000 patients last year, and Pfizer expects more this year because of the soaring cost of many drugs.
For more information about financial aid and discounts offered by other drugmakers, see our Patient Resources section.