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About REQUIP XL

REQUIP XL is the first and only oral once-daily dopamine agonist indicated for both early and advanced Parkinson’s disease. REQUIP XL is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. It may be taken alone or in combination with L-dopa.

Efficacy of REQUIP XL

Improvement in activities of daily lliving (ADL) and motor performance scores at week 24
  • 25% improvement in ADL score with REQUIP XL vs 6% with placebo in a 24-week study 3
  • 22% improvement in motor performance score with REQUIP XL vs 6% with placebo in a 24-week study 3

 * A 6-month, randomized, double-blind, placebo-controlled study of 391 patients with Parkinson's disease who were not optimally controlled with L-dopa. As adjunctive therapy to L-dopa, patients were randomized to either REQUIP XL + L-dopa or placebo + L-dopa. The primary end point was mean change from baseline in hours "off" at week 24.

Protocol-specified secondary end point at week 24; other secondary end points were measured and can be found in the EASE-PD adjunct publication.

Mean change from baseline in UPDRS score at week 24 LOCF.

§ The ADL component of the UPDRS ranges from 0 to 52. ADL score at baseline was approximately 14.

|| The motor component of the UPDRS ranges from 0 to 108. Motor score at baseline was approximately 30.



Significant reduction in daily off time within 2 weeks and continued through week 24

In addition to reducing "off" time, REQUIP XL, as an adjunct to L-dopa, demonstrated an average increase in "on" time of 1.6 hours without troublesome dyskinesias compared with placebo3

As an adjunct to L-dopa, REQUIP XL reduced "off" time by more than 2 hours, with an average L-dopa dose reduction of 34%3**


Reduction in daily

  • 34% reduction in L-dopa dose in patients treated with REQUIP XL compared to 21% with placebo 3¶††
  • 93% of patients treated with REQUIP XL maintained reduction in daily
    L-dopa dose vs 72% receiving placebo (P<0.001) 3¶††

A 6-month, randomized, double-blind, placebo-controlled study of 391 patients with Parkinson’s disease who were not optimally controlled with L-dopa. As adjunctive therapy to L-dopa, patients were randomized to either REQUIP XL + L-dopa or placebo + L-dopa. The primary end point was mean change from baseline in hours “off” at week 24.

# Statistical significance was achieved at each assessment point except week 1.

** Adjusted mean treatment difference between REQUIP XL and placebo of -1.7 hours.

†† Protocol-specified secondary end point at week 24; other secondary end points were   measured and can be found in the EASE-PD adjunct publication.

What are the differences between REQUIP XL and immediate-release ropinirole?

REQUIP XL is a once-a-day formulation of ropinirole for treating Parkinson’s disease using SkyePharma PLC’s patented GEOMATRIX technology. REQUIP XL has been designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. Immediate-release ropinirole is dosed TID. Additionally, REQUIP XL offers physicians and patients a fast and simpler titration schedule compared to immediate-release ropinirole. The starting dose and titration schedules are different between REQUIP XL and immediate-release ropinirole.

Important Safety Information About REQUIP XL

REQUIP XL has been associated with sedating effects, including somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope or symptomatic hypotension may occur more frequently during initial treatment or with an increase in dose. Increase in blood pressure and changes in heart rate may occur. Hallucinations may occur at any time during treatment. Impulse control symptoms, including pathological gambling and hypersexuality, have been reported in patients treated with dopaminergic agents, including ropinirole. REQUIP XL may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate pre-existing dyskinesia.