Pfizer Inc. (PFE) announced that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - show that Lyrica does not affect the reproductive function in healthy males when compared to placebo.
The company noted that the study was conducted as a post-approval commitment required by the US Food and Drug Administration, or FDA. Pfizer added that it will continue to further analyze the study results.
The purpose of the Phase 4, multicenter, double-blind, randomized, placebo-controlled study was to assess the effects of Lyrica as compared to placebo on sperm concentration in healthy males. The primary endpoint of the study, the proportion of subjects with a 50 percent or more reduction in sperm concentration from baseline to end of study (week 26) last observation, was met. The most common adverse events in subjects who received Lyrica compared to those who received placebo were dizziness, somnolence, dissociation and fatigue. The adverse event profile is consistent with that known for Lyrica.
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