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Apomorphine may reduce ‘off’ time for patients with advanced Parkinson’s disease

Apomorphine may provide relief for patients with Parkinson’s disease during periods of immobility related to temporary unresponsiveness to medication, known as “off” time, according to new data presented at the 69^th Annual American Academy of Neurology Meeting.

Levodopa has long been considered the gold standard treatment for improving quality of life in patients with Parkinson’s disease, according to a press release. However, as the disease progresses, people experience off time as the effects of the medication wear off more quickly after each dose. Apomorphine has been used for decades to treat advanced Parkinson’s disease, but there isn’t sufficient evidence of its effectiveness and safety from randomized, blinded studies.

Regina Katzenschlager, MD, from Danube Hospital, affiliated with the Medical University of Vienna, and colleagues examined the efficacy of apomorphine subcutaneous infusion compared with placebo saline infusion in reducing off time among patients with Parkinson’s disease who have motor fluctuations poorly controlled by conventional therapy. They randomly assigned 107 participants from seven different countries to receive either apomorphine or placebo administered over a period of 14 to 18 hours each day. Patients used diaries to record changes in off time from baseline to week 12.

The results showed that within the first week of treatment, participants who received apomorphine had a significantly greater reduction in off time compared with those who received placebo. On average, those who received apomorphine experienced 2.5 hours less off time per day, while those who received placebo experienced 30 minutes less off time per day. The researchers found that those who received apomorphine had an increase of “on” time without the abnormal involuntary movements commonly observed with levodopa. When asked to evaluate their treatment, participants who received apomorphine gave the therapy higher scores at week 12 compared with those who received placebo. The investigators observed that 71% of apomorphine patients reported improvementscompared with only 18% of those receiving placebo. They also found that 19% reported worsening on apomorphine, compared to 45% of those receiving placebo. They observed no serious adverse side effects.

“If a person with Parkinson’s disease can reduce their ‘off’ times, that can have a great impact on their everyday life,” Katzenschlager said in the press release. “It is our hope that these findings confirming the efficacy of apomorphine infusion will encourage doctors in the United States to offer this treatment to their patients and assess its efficacy in their own clinical practice.”

The FDA recently approved another drug, Xadago, for patients who are currently assigned levodopa/carbidopa and are experiencing off episodes. – by Savannah Demko

Reference:

Katzenschlager R, et al. “Double-blind, randomized, placebo-controlled, Phase III study (TOLEDO) to evaluate the efficacy of apomorphine subcutaneous infusion in reducing OFF time in Parkinson’s disease patients with motor fluctuations not well controlled on optimized medical treatment.” Presented at: American Academy of Neurology 69^th Annual Meeting; Apr. 22-28, 2017; Boston.

Disclosure: This study was supported by Britannia Pharmaceuticals Ltd.