PREPARED Study Demonstrates Requip-Modutab Is a Highly Effective Treatment in the Management of Parkinson's Disease
- A single daily dose of ropinirole delivers predictable, continuous control of symptoms day and night -
CHICAGO, June 24, 2008- New data presented today at the 12th International Congress of Parkinson's Disease and Movement Disorders prove that ropinirole is a highly effective molecule in managing Parkinson's disease (PD). Results from the PREPARED study confirm that Requip-Modutab* (ropinirole prolonged release tablets) offers a highly effective and more simplified treatment regimen compared to ropinirole 3x daily, by providing continuous delivery of ropinirole day and night from a single daily dose1.
Professor Stocchi, lead trial investigator and Professor of Neurology, IRCCS San Raffaele, Rome, Italy commented: "For PD patients, continuous control of symptoms throughout the day and night is critical. Patients currently experience unpredictability in managing their disease on a daily basis. The results of the PREPARED study verify that Requip-Modutab is extremely effective in treating the complex, unpredictable nature of the disease. By using the Requip-Modutab treatment approach, patients are able to achieve clinically more significant outcomes compared with the intermittent delivery of ropinirole 3x daily. The improvement in symptom control provided by Requip-Modutab should significantly improve patients' quality of life."
The study compared two treatment approaches using once-daily Requip-Modutab and the ropinirole 3x daily formulation as adjunct therapy in patients with advanced PD. Patients using Requip-Modutab maintained a ?% reduction in 'off' time versus those taking ropinirole 3x daily (66% versus 51%) and were able to achieve a greater reduction in L-dopa dose compared with the 3x daily formulation. By using Requip-Modutab, patients are more easily able to access the full range of doses. Therefore the most clinically appropriate treatment dose can be reached more rapidly and simply than with ropinirole 3x daily. Whilst patients were able to reach higher doses with Requip-Modutab (mean dose of 18.6mg/day versus 8.9mg/day with ropinirole 3x daily), both treatment formulations were generally well tolerated.
Data from the study confirm that patients taking adjunctive Requip-Modutab demonstrate significant improvement on the CGI-I scale (54% versus 42% for ropinirole 3x daily) highlighting better patient outcomes with the Requip-Modutab treatment approach compared with intermittent delivery of ropinirole 3x daily.
In addition, a recent adherence survey suggests that therapies that offer simplified dosing regimens and provide less intermittent dosing during the day may reduce tablet burden, improve adherence and result in optimal symptom management2. Interim results from a pan-European survey revealed that 42% of PD patients (n= 1,026) needed to plan their day around the times they take their medication, highlighting an unmet need for simplified treatment regimens3.
Requip-Modutab uses SkyePharma PLC's (LSE: SKP) patented GEOMATRIX(r) technology. The new formulation has been developed to provide a continuous delivery of ropinirole over 24 hours, resulting in reduced fluctuations in plasma concentrations associated with ropinirole 3x daily. Requip-Modutab is the first and only oral non-ergot once daily dopamine agonist for the treatment of PD.
Ropinirole (ReQuip) was developed by and is marketed by GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies. For detailed company information, see GlaxoSmithKline's website: www.gsk.com <http://www.gsk.com/> .
About SkyePharma PLC
Using it proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules.š The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com <http://www.skyepharma.com/> .
Notes to Editors
ABOUT THE PREPARED STUDY
The PREPARED study was a randomised, double-blind, double-dummy, parallel group study which compared treatment approaches using Requip-Modutab and ropinirole 3x daily as adjunct therapy over 24 weeks in patients with advanced PD. The primary endpoint was the percentage of patients maintaining a ?% reduction from baseline in 'off' time over two consecutive visits at week 24.
ABOUT THE ADHERENCE STUDY
The study assessed adherence among 250 PD patients taking ropinirole immediate release (IR) at least three times daily (TID), patient-reported drivers and consequences of non-adherence, and interest in a once daily formulation of ropinirole. The survey reported that patients were not adherent with their medications for a variety of reasons. Nonadherence resulted in breakthrough symptoms that affect quality of life.
Requip-Modutab has been approved and launched in 15 European countries (Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Slovak Republic, Slovenia, Sweden, Switzerland, UK).
*Requip-Modutab will also be known as Requip LP, Requip XL, Requip Depot, Requip Prolib and Requip prolonged release tablets.
1. Schapira HV et al.,editors. Abstract for the 12th International Congress of Parkinson's Disease and Movement Disorders; 2008 22-26 June; Chicago, USA
2. Edin HM et al., editors. Abstract for the 12th International Congress of Parkinson's Disease and Movement Disorders; 2008 22-26 June; Chicago, USA
3. EPDA. Real Life, Real PD Survey Interim Pan-European Results. 2007
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Posted: June 2008