Pfizer’s Lyrica (pregabalin) has failed to hit its primary target in a post-marketing study assessing its safety and efficacy in young people with fibromyalgia.
The drug giant said that in the Phase IV study there was not a statistically significant difference in the mean pain score between 12-17 year-olds taking the drug and those taking a placebo.
Steve Romano, who heads up Global Medicines Development for the Pfizer Global Innovative Pharmaceutical business, said the findings “advance the understanding of this patient population” but “do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults”.
On the safety side, observations were consistent with the known profile for Lyrica in prior fibromyalgia studies in adults, with the exception of mild nausea, which was seen more frequently in pregabalin-treated patients. Overall, the most common side effects reported in the treatment arm were dizziness, nausea, headache, increased weight and fatigue.