Study confirms Apomorphine subcutaneous infusion’s established role in PD
Posted in News Review on 27th Apr 2017
Results from the first randomised, 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.
Katzenschlager R, et al. Poster 003 presented at the 69th American Academy of Neurology Annual Meeting, Boston, MA, USA, 22–28 April 2017.