GSK Announces Regulatory Approvals For Requip-Modutab, The First And Only Oral Once-Daily Non-Ergot Dopamine Agonist For Parkinson's Disease

Main Category: Parkinson's Disease
Also Included In: Neurology / Neuroscience
Article Date: 13 Dec 2007 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

GlaxoSmithKline announced the approval of Requip Modutab* (ropinirole prolonged release tablets) in eight European countries**. In addition, a mutual recognition procedure was recently completed in 17 additional countries in the European Union***. This should result in approval and launches in these countries from the first quarter of 2008 onwards. Ropinirole prolonged release tablets is the first and only oral non-ergot once daily dopamine agonist for the treatment of Parkinson's Disease (PD).

Ropinirole prolonged release tablets represent a significant clinical advancement in the treatment of PD. The new formulation uses SkyePharma's PLC's (LSE: SKP) patented GEOMATRIX® technology and has been developed to provide a continuous delivery of ropinirole over 24 hours resulting in reduced fluctuations in plasma concentrations associated with the three times daily immediate release tablet formulation of ropinirole.

Professor Fabrizio Stocchi, Professor of Neurology, IRCCS San Raffaele of Rome, Italy, comments: "An important goal of PD treatment is to provide continuous control of symptoms over a 24-hour period. Although several therapies have been developed in an attempt to provide continuous delivery, there remains a significant need for improvement. This need may be met by a once daily oral formulation of ropinirole. By providing continuous delivery of ropinirole, symptoms will be effectively controlled during the day and night, having a positive impact on patients' quality of life.'

PD is caused by degeneration of dopamine-containing neurons in the brain1. In the healthy brain dopamine release is regular and mechanisms act to ensure a relatively continuous receptor stimulation. The ideal PD treatment should mimic the effect of lost dopamine, however the majority of existing treatments for PD are associated with fluctuations in symptom control1. One goal in the treatment of PD is to provide control of symptoms during the day and night.2

The clinical efficacy of ropinirole prolonged release tablets were established in two Phase III, randomised, double-blind studies in both early (Study 168, conducted in 161 patients) and advanced PD (Study 169, conducted in 393 patients) which are collectively referred to as EASE-PD3,4.

A recent survey reported today by the European Parkinson's Disease Association (EPDA), highlighted important aspects of PD as well as the unpredictability of the disease and need for improved symptom control. The Real Life, Real PD survey which was presented today revealed that more than two thirds of patients with PD do not feel in complete control of their symptoms over a 24-hour period5. The survey also concluded that PD affects patients' emotional wellbeing and their ability to have a restful sleep ultimately having a significant impact on quality of life.

Susanna Lindvall, Vice President of the EPDA comments: 'Real Life, Real PD demonstrates that there is a high unmet need for better control of PD symptoms during both the day and night. The EPDA welcomes these insights into the realities of living with PD which we hope will encourage physicians managing Parkinson's to recognise the importance of non-motor symptoms, and the impact that they have on quality of life, as part of their overall treatment strategy.'

Interim results from Real Life, Real PD revealed that:

- Over half of patients surveyed experience difficulties in getting to sleep and 72 percent wake at least once during the night. Moreover, 19 percent of these respondents admitted to waking more than four times during the night

- 68 percent of patients experience worry, 60 percent experience low mood and 59 percent experience frustration related to their PD

- Over three quarters of patients felt that changes in their mood can have a negative impact on their relationships with friends, colleagues and family members

- Anxiety, fear, embarrassment, anger and confusion were also experienced

The Real Life, Real PD Survey was sponsored by GSK.

About GlaxoSmithKline

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: http://www.gsk.com.

About SkyePharma PLC

Using it proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. 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 http://www.skyepharma.com.

Notes:

* Requip Modutab prolonged release tablets will also be known as Requip LP, Requip XL Requip Depot and Requip prolonged release tablets.
** Requip Modutab is currently approved in France (as Requip LP), Switzerland, Hungary, Slovenia, Slovakia, Czech Republic, Estonia and Latvia
***The 17 concerned member states of the European Union where the mutual recognition procedure was conducted are: Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, Cyprus, Malta, Lithuania and Poland.

About the survey

The Real Life Real PD Survey was developed in partnership with a European steering committee of experts in PD and was conducted in conjunction with the European Parkinson's Disease Association (EPDA) and GSK

References

1. Samii A et al. Lancet 2004; 363: 1783-93
2. Dhawan B et al. Age Ageing 2006; 35 :220-228
3. Stocchi F and Giorgi L. Eu J Neurol 2006;13 (S2):205 p2141
4. Pahwa R. et al. Neurology 2007; 68:1108-1115
5. Real Life, Real PD Survey Interim Results, November 2007

GlaxoSmithKline