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news.Pfizer has reported positive top-line results from Lyrica (pregabalin) capsules CV Study A0081104 which evaluated the effect of Lyrica on male reproduction conducted as a post-approval commitment required by the FDA.
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The Phase 4, multicenter study has met the primary endpoint, the proportion of subjects with a 50% or more reduction in sperm concentration from baseline to end of study (week 26) last observation.
The results demonstrated that Lyrica does not affect the reproductive function in healthy males when compared to placebo. The company is expected to continue further analysis of the study.
Out of 222 subjects that were randomised in the study, 111 subjects received Lyrica and 109 subjects received placebo for 12 weeks followed by a three-month washout period.
Subjects in the Lyrica arm received 600mg/day (300mg twice daily) for 10 weeks after a two-week titration that started at 100mg/day (50mg BID).
Subjects who could not tolerate 600 mg/day had their dosage reduced to 450mg/day (225 mg BID) and those who were unable to tolerate 450mg/day were dropped from the study.
Dizziness, somnolence, dissociation and fatigue were the most common adverse events observed in subjects who received Lyrica compared to those who received placebo.