Blow for Pfizer as Lyrica misses target
pharmafile | March 13, 2015 | News story | Sales and Marketing | FDA, Lyrica, Pfizer, fibromyalgia, pain, pregablin
A late-stage study of Pfizer’s Lyrica has failed to demonstrate it has any significant pain reduction in patients with fibromyalgia.
The international randomised controlled trial compared 107 adolescents aged between 12 and 17 years with fibromyalgia (widespread pain), who were treated either with Lyrica (pregablin) or a placebo for 15 weeks.
But neuropathic pain treatment failed to show any significant difference in mean pain reduction score compared to people taking a placebo. The difference was 0.66 points, an improvement of 1.60 points from baseline for patients treated with Lyrica, compared with 0.94 points for patients given a placebo.
The late-stage failure in what is the first large pharmacological treatment study to be completed in this study population will be a blow to Pfizer, that was asked by the FDA to establish the safety and efficacy of Lyrica. In the US it is approved for fibromyalgia but any benefits in paediatric patients are uncertain.
In a statement Pfizer says it will still submit the full results when the analysis is complete, but looks to have taken a setback in regards to any plans to file regulatory applications in this patient group.
This news arrives as Pfizer’s recent financial results showed Lyrica performed strongly in 2014 sales, and was one of the key drugs which drove the company’s operational growth – despite revenue declining by 3% overall.
Steve Romano, senior vice president and head of global medicines development for the Pfizer global innovative pharmaceutical business, says the company will continue to pursue pain treatments in paediatric and adolescents.
“This study advances the understanding of this patient population. Lyrica has more than 10 years of real world experience supporting the needs of patients and remains an important treatment choice for healthcare professionals. These results do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults.”
Lilian Anekwe
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