READING, England, April 25, 2017 /PRNewswire/ --
Results from the first randomized, controlled trial investigating the efficacy and safety of APO-go®/MOVAPO® (apomorphine) subcutaneous infusion in Parkinson's disease (PD) patients whose motor symptoms are not controlled by other therapies - the TOLEDO study - were presented during the 'Emerging Science' session at the American Academy of Neurology (AAN) Annual Meeting in Boston, USA, on 25th April 2017. The session highlighted the best neuroscientific research at the congress.
Although APO-go®/MOVAPO® infusion has been used successfully in clinical practice for almost 30 years in Europe and many uncontrolled studies have shown its benefits in decreasing 'off' time, improving dyskinesias and reducing the need to take oral levodopa, to date these observations have not been confirmed in the setting of a controlled clinical trial.
Professor Katzenschlager, the lead investigator of TOLEDO, presented the results of the 12-week, double-blind phase undertaken in 107 patients from 23 centres around Europe. Patients treated with APO-go®/MOVAPO® infusion had a significantly greater improvement in 'off' time from baseline to Week 12 compared with those on placebo, resulting in a difference between treatments of almost 2 hours. The effect of APO-go®/MOVAPO® was rapid: a reduction in 'off' time was observed at the first assessment at Week 1 and was sustained over the 12 weeks of the study. Importantly, this clinically meaningful reduction in 'off' time was achieved without an increase in dyskinesias and was reflected in the patients´ own assessment of the overall treatment effect.
Professor Katzenschlager commented: "TOLEDO provides the high-level evidence we needed for the efficacy and tolerability of apomorphine infusion in patients who are still experiencing debilitating treatment response fluctuations despite receiving optimized treatment, and confirms the clinical experience of those who have used apomorphine infusion for many years. The trial also gives us a 'tried and tested' initiation protocol that clinicians can follow and adapt to their own clinical setting. The impressive results should give them added confidence to prescribe this valuable but underused therapy."
The TOLEDO study is sponsored by Britannia Pharmaceuticals Ltd., part of the STADA Arzneimittel AG group of companies and manufacturer of apomorphine products (APO-go®/MOVAPO®/APOKYN®). The open-label phase of TOLEDO is ongoing and results are expected in 2018.
Reference
Katzenschlager R, et al. Poster 003 presented at the 69th American Academy of Neurology Annual Meeting, Boston, MA, USA, 22-28 April 2017.
Background:
Founded in 1982, Britannia Pharmaceuticals Limited is a pharmaceutical company based in Reading, UK, specialising in the neurology market. The company's primary expertise is in the development and marketing of products in the area of PD. Working closely for over 30 years with neurologists and geriatricians, Britannia identified the benefit of and need for apomorphine as a treatment for PD, which led to the development of APO-go®/MOVAPO®/APOKYN® products. The product is available in 23 countries round the world.
Britannia is owned by Frankfurt-based STADA Arzneimittel AG. APO-go® is amongst the TOP 5 branded products of the STADA Group.
APO-go® products are marketed in the UK by Britannia Pharmaceuticals Ltd and transferred with the acquisition of Britannia into the STADA portfolio in 2007. APO-go® products are marketed outside the UK through own affiliates and licensing partners.
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