The
treatment was compared to placebo and an alternative drug therapy in a study
called A0081186, which involved more than 700 patients and took place over 12
months.
It was found that Lyrica was able to deliver a statistically significant improvement in terms of treatment response, reduction of RLS symptom severity and minimising the rate of augmentation, thus meeting all three of its co-primary endpoints.
Previous top-line phase III study data has also indicated that Lyrica can provide improved sleep maintenance compared with placebo among adults with RLS.
It was found that Lyrica was able to deliver a statistically significant improvement in terms of treatment response, reduction of RLS symptom severity and minimising the rate of augmentation, thus meeting all three of its co-primary endpoints.
Previous top-line phase III study data has also indicated that Lyrica can provide improved sleep maintenance compared with placebo among adults with RLS.
Currently, Lyrica is approved in 110 countries for a variety of conditions, although Pfizer does not presently intend to submit the drug for approval as an RLS treatment.
Earlier this month, the company reported positive data from another phase III trial called A0221049, showing the efficacy of its overactive bladder treatment Toviaz among elderly patients.
