Data from phase III TOLEDO study of APO-go/Movapo in Parkinsons disease published in Lancet Neurology.- Britannia Pharma.
Britannia Pharma announced publication of the results of the double-blind phase of the phase III TOLEDO study of APO-go/Movapo (apomorphine) in parkinsons disease (PD), in Lancet Neurology. Treatment with APO-go/Movapo subcutaneous infusion for 12 weeks gave significantly greater reductions in OFF time (periods when PD medications don't work) from baseline compared with placebo: -2.47 h/day versus -0.58 h/day, respectively - a treatment difference of almost 2 hours (p=0.0025) and double the change in OFF time recognised as meaningful to PD patients. These reductions were seen in the first week of treatment with APO-go/Movapo infusion.
Compared with placebo, significantly greater increases in ON time (periods with good motor control) without troublesome dyskinesia - 'good' ON time - from baseline were observed with APO-go/Movapo infusion: 2·77 h/day versus 0·80 h/day, respectively (p=0·0008), and patients could also reduce the dosage and number of administrations of concomitant oral PD medications significantly (p=0.0014). Clinical improvements were reflected in patients' assessment of treatment: significantly more APO-go/Movapo infusion patients rated themselves as 'improved' (71%) versus placebo (18%; p<0.0001).
Comment: TOLEDO is the first multicentre, randomised, double-blind trial to investigate its efficacy and safety in PD and was undertaken in 107 patients from 23 hospitals in 7 countries whose symptoms were uncontrolled despite taking multiple medications.
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