Pfizer reports disappointment with Ph III trials of Lyrica in extended indications

8 May 2012

US drugs behemoth Pfizer (NYSE; PFE) had a setback with extending the use of its blockbuster drug Lyrica (pregabalin) last Friday, reporting that it had stopped a Phase III trial of the drug  for diabetes and HIV patients after it failed to meet the studies’ primary goal and another as a treatment for patients suffering diabetes-related nerve damage, which disappointed.

These results would suggest no expansion into new growth areas for Lyrica, currently approved to treat diabetic nerve pain, pain after shingles, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. Lyrica generated sales of $955 million in the first quarter of this year.

The decision to halt study A0081244 follows review of a planned interim analysis of the research data by the trial’s external Data Monitoring Committee (E-DMC). There were no safety concerns raised in the E-DMC review of the interim data, said Pfizer.

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