Lyrica fails in diabetes and HIV pain
pharmafile | May 9, 2012 | News story | Sales and Marketing | Lyrica, Pfizer, neuropathic pain, pain
Two separate Phase III trials of Lyrica have failed to show benefits in treating nerve pain – one in HIV patients, one in diabetes patients.
Lyrica (pregabalin) is approved in the US for treating fibromyalgia, diabetes and other pain management, and had sales of $3.7 billion last year, making it one of the company’s most important earners.
Pfizer had hoped to extend its uses, and disappointing results in the difficult-to-treat conditions are a clear setback for the company.
The first trial (named A0081242), found Lyrica did not significantly reduce the pain suffered by diabetes patients who were switched to the drug to control their pain after another treatment had failed.
Painful diabetic peripheral neuropathy is a form of nerve damage characterised by burning pain, pins and needles, or shooting pain in the feet and hands. Around 20% of people with diabetes experience pain resulting from nerve damage.
The second Phase III trial looked at Lyrica in patients with neuropathic pain associated with HIV neuropathy, which is characterised by burning pain, usually beginning in the feet.
The company has halted the trial after an interim analysis by the trial’s external Data Monitoring Committee showed there was no benefit to continuing treatment. There were no safety concerns raised in the E-DMC review, however.
The most common adverse events in patients taking the drug were peripheral oedema, dizziness, somnolence and upper respiratory tract infection when compared with placebo, which are well-established side effects of the drug.
Steven Romano, senior vice president and head of Pfizer’s Medicines Development Group, said the results showed the ‘complexities of studying pain’ particularly in neuropathic pain associated with HIV neuropathy, for which there are no approved medications in the US.
The results are bad news for Pfizer who is already suffering heavy damage to revenues from the patent expiry of Lipitor, and will restrict further growth in Lyrica sales.
Brett Wells
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