Produodopa available to treat advanced Parkinson’s in Scotland

24-hour levodopa infusion therapy added to country's public health system

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by Andrea Lobo |

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Produodopa (foslevodopa/foscarbidopa; also known as ABBV-951), a continuous infusion formulation of levodopa/carbidopa, will be available to advanced Parkinson’s disease patients in Scotland whose severe motor fluctuations and involuntary movements are no longer controlled by those standard therapies.

The Scottish Medicines Consortium (SMC) restricted use of AbbVie’s subcutaneous (under-the-skin) 24-hour infusion therapy to people who are not eligible for deep brain stimulation (DBS) and in need of treatment options.

Eligible patients can access Produodopa through the country’s public health system, which generally makes the treatment more affordable.

“The SMC’s decision to make this treatment available on the NHS [National Health Service] in Scotland means that eligible patients across the UK will now be able to access this treatment option,” Rachael Millward, medical director at AbbVie UK, said in a company press release.

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As Parkinson’s disease advances, oral levodopa loses its effectiveness

A similar regulatory approval and NHS listing was given Produodopa and its use in England last year.

“Given the individual nature of Parkinson’s disease and associated symptoms, some treatments may not be suitable for certain patients. As such, providing a choice around therapies for those with advanced or complex stages of the condition is important,” said Esther Sammler, MD, PhD, a consultant neurologist at the University of Dundee.

Produodopa, supported by data from two Phase 3 clinical trials showing its use reduced motor fluctuations, has been approved in the European Union, the U.K., Canada (under the brand name Vyalev), and Japan. The U.S. Food and Drug Administration (FDA) has requested more information on the specialized pump used to administer the medication before considering it for approval.

In Parkinson’s disease, the progressive loss of nerve cells that produce dopamine, an important brain signaling chemical, leads to impaired dopamine signaling and disease symptoms.

Levodopa, which is converted to dopamine in the body, is a mainstay oral treatment of Parkinson’s motor symptoms. Levodopa is usually combined with carbidopa to prevent its conversion into dopamine before reaching the brain.

However, long-term treatment leads to prolonged off episodes, periods when Parkinson’s symptoms return between medication doses. A need for higher and more frequent levodopa doses often causes dyskinesia, characterized by involuntary and uncontrolled movements.

A continuous infusion, Produodopa is designed to minimize off periods

Produodopa is a soluble formulation of prodrug versions of levodopa/carbidopa, which are converted to the active medication once inside the body, given as a continuous infusion using a pump. It is designed to provide more stable levodopa levels, thereby minimizing off episodes.

It “offers an additional treatment option that can be self-administered, or administered with the assistance of a caregiver, when currently available combinations of treatments have failed to provide satisfactory results,” Sammler said.

Findings in two Phase 3 trials of Produodopa supported its approvals: the M15-736 study (NCT04380142) and the M15-741 study (NCT03781167).

M15-736 enrolled 141 patients with advanced Parkinson’s and uncontrolled motor fluctuations, despite treatment with oral levodopa/carbidopa. They randomly were assigned to either Produodopa and oral placebo capsules, or to a continuous and subcutaneous placebo infusion plus oral immediate-release levodopa/carbidopa for 12 weeks (about three months).

Trial data showed that people treated with Produodopa had significantly higher control of motor symptoms without troublesome dyskinesia and reductions in off time, compared with those given oral levodopa/carbidopa.

Similarly, data from the open-label M15-741 study showed that Produodopa’s continuous use eased motor fluctuations. After one year of treatment, patients experienced an average of 3.58 more daily hours of on time — periods with adequately controlled motor symptoms — and an average of 3.39  fewer daily hours of off time.

The most frequent adverse events in patients given Produodopa in these studies were infusion site reactions, hallucinations, falls, and anxiety.