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Pfizer has announced that its Lyrica (pregabalin) capsules have met each of its three co-primary endpoints in the Phase III study evaluating it in patients with restless legs syndrome.
Restless legs syndrome is a neurological condition that is featured by an unpleasant irresistible urge to move the legs and, in severe cases, other parts of the body.
The 12-month, randomised and double-blind A0081186 trial enrolled more than 700 patients, who received either a placebo, Lyrica at 300mg/day, pramipexole at 0.25mg/day or pramipexole at 0.5mg/day.
The study reported that patients treated with Lyrica demonstrated a considerable improvement in restless legs syndrome symptom severity as measured by the International Restless Leg Group Rating Scale compared with placebo following 12 weeks of treatment.
In the trial, the Lyrica group showed an improvement in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale, following 12 weeks of treatment.
Treatment with Lyrica also reduced the rate of augmentation, which is the worsening of restless legs syndrome symptoms that occur after starting a medication, compared with pramipexole 0.5mg/day over 12 months.
The Phase III study also showed that Lyrica demonstrated considerable improvements in the primary endpoint, sleep maintenance, compared with the placebo in adults.
Previous preliminary study results indicate that the common adverse events in Lyrica-treated patients were dizziness, somnolence, headache, nausea, dry mouth, upper respiratory tract infection and disturbance of attention.
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