Bial is pleased to announce that Ongentys® (opicapone) has been accepted for use within NHS Scotland following review by the Scottish Medicines Consortium (SMC) for adult patients with Parkinson’s disease as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) with end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Parkinson’s disease is a chronic and progressive neurodegenerative disorder[i] which affects an estimated 14,587 people in Scotland[ii].

With this decision by the SMC, Scotland has become first of the four UK Nations to enable unrestricted equitable access to Ongentys® to suitable patients with Parkinson’s disease. Prior to this approval, some of these patients would have required more invasive therapies such as injection, infusion or pump to manage their condition if other treatments failed.

Dr Donald Grosset, former Consultant Neurologist at the Queen Elizabeth University Hospital in Glasgow who is active in Parkinson’s clinical research welcomed the news. He said: “It is always very helpful to have a range of treatment choices that can be tailored for each individual person with Parkinson’s.”

Tanith Muller, Parliamentary and Campaigns Manager at Parkinson’s UK Scotland said: “Parkinson’s UK Scotland welcomes the approval of opicapone for use in NHS Scotland. It means that people with Parkinson’s who experience debilitating symptoms will have another treatment option. ‘Wearing off’ happens when a person’s Parkinson’s medication stops working before the next dose is due. It can happen suddenly, leaving people unable to move or speak. Some people have anxiety or uncontrolled movements. Wearing off has a huge impact on people with Parkinson’s and family members or friends who support them – some people feel unable to leave their homes. Wearing off can be hard to treat and having a different option to consider means that more people with Parkinson’s in Scotland can gain greater control of their symptoms – and their lives.”

Ongentys® is a once-a-day oral COMT (Catechol-O-methyltransferase) inhibitor which can block COMT, an enzyme that breaks down levodopa, which is the gold standard therapy for controlling motor symptoms in patients with Parkinson’s disease. It can reduce the symptoms of Parkinson’s disease by helping to protect levodopa against this enzyme by reducing its breakdown in the bloodstream, making more levodopa available to reach the brain.

The marketing authorisation of Ongentys® (opicapone) is supported by data from two multinational Phase III clinical studies (BIPARK I and BIPARK II). In BIPARK I, approximately 600 patients with Parkinson’s disease and motor fluctuations received one of three doses of opicapone (5 mg, 25 mg or 50mg), placebo or 200 mg doses of the COMT inhibitor entacapone for 14 or 15 weeks. In the BIPARK II trial, approximately 400 patients received one of two doses of opicapone (25 mg or 50 mg) or placebo for 14 or 15 weeks. The data from both trials showed that opicapone 50 mg significantly reduced the periods during the day when Parkinson’s medication does not work and symptoms worsen (OFF-time) and increased the periods during the day when medication works and symptoms improve (ON-time), from baseline to week 14 or 15 compared to placebo[iii].

Securing patient access to Ongentys® in Scotland is part of Bial’s ongoing commitment to improving the quality of life for patients living with Parkinson’s disease and their families.