Pfizer Phase 4 Lyrica capsules CV Study meets primary endpoint

24th July 2012 (Last Updated July 24th, 2012 18:30)

Pfizer has reported the top-line results of Lyrica (pregabalin) capsules CV Study A0081104, which demonstrated the effect of Lyrica on male reproduction.

Pfizer

Pfizer has reported the top-line results of Lyrica (pregabalin) capsules CV Study A0081104, which demonstrated the effect of Lyrica on male reproduction.

Conducted as a post-approval commitment required by the FDA, the Phase 4, multicentre study results showed 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.

The primary endpoint of the double-blind, placebo-controlled study, the proportion of subjects with a 50% or more reduction in sperm concentration from baseline to end of study (week 26) last observation, was met.

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 ten weeks after a two-week titration that started at 100mg/day (50mg BID).

Subjects who could not tolerate 600mg/day had their dosage reduced to 450mg/day (225mg 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.

In the US Lyrica is indicated for diabetic nerve pain, post herpetic neuralgia (pain after shingles), fibromyalgia, neuropathic pain associated with spinal cord injury and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.


Image: Pfizer Lyrica does not affect the reproductive function in healthy males when compared to placebo. Image: Jim.henderson