Pfizer Inc. (PFE) said Monday a Phase 4 study of its blockbuster drug Lyrica showed it does not affect the reproductive function in healthy males when compared to placebo. Additionally, Pfizer also announced positive results for Lyrica from a study of the drug's discontinuation in subjects with Generalized Anxiety Disorder.
The Phase 4 study on reproductive function was in line with a post-approval commitment requirement by the US Food and Drug Administration. The objective of the study was to assess the effects of Lyrica (pregabalin) as compared to placebo on sperm concentration in healthy males.
A total of 222 subjects were randomized. Subjects in the Lyrica arm received 600 mg/day for 10 weeks after a 2-week titration that started at 100 mg/day.
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 events in subjects who received Lyrica were dizziness, somnolence, dissociation and fatigue.
Lyrica is approved for various indications globally. In the U.S., the Lyrica is indicated in diabetic nerve pain, post herpetic neuralgia, and fibromyalgia. In Pfizer's first quarter, Lyrica generated sales of $955 million, up 16 percent from last year.
Pfizer last Thursday said a U.S. Court upheld its composition of matter patent, as well as pain and seizure use patents covering Lyrica. Pfizer said it will exclusively provide pregabalin as Lyrica to patients through December 30, 2018 in the U.S., pending generic company appeal and further litigation.
Separately, Pfizer announced positive results for Lyrica from a study of the drug's discontinuation in subjects with Generalized Anxiety Disorder, or GAD. Results showed that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients.
The study was requested by the European Medicines Agency, or EMA, to investigate the relationship between dose and duration of treatment on discontinuation symptoms following long-term treatment with Lyrica in GAD patients.
Lyrica is approved for the treatment of GAD in adults in the European Union and several other regions around the world, but not in the U.S.
Shares of Pfizer are trading at $23.58, down 0.58%, on a volume of 12 million shares on the NYSE.
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