Date: {{$ActivityAssignDate}}

Dear Dr. {{$doctorName}},

Subject: A retrospective, cross-sectional observational survey study to analyse the role of Safinamide in patients with Parkinson’s Disease

Parkinson’s disease (PD) is a chronic progressive neurodegenerative disorder characterized by early prominent death of dopaminergic neurons in the substantia nigra pars compacta (SNpc) and wide spread presence of alpha synuclein (aSyn), an intracellular protein. Parkinson’s disease is the second-most common neurodegenerative disorder that affects 2–3% of the population ≥65 years of age.¹ Age is the greatest risk factor for the development of Parkinson’s disease. PD is twice more common in men than in women in most populations.² There is no homogenous and large epidemiological data on PD from India. A study reported a crude prevalence rate of 14.1 per 100,000 amongst a population of 63,645 from rural Kashmir in the northern part of India. The prevalence rate over the age of 60 years was 247/100,000.³

Parkinson’s disease is clinically defined by the presence of bradykinesia and at least one additional cardinal motor feature (rigidity or rest tremor). Non-motor symptoms involve a multitude of functions, including disorders of sleep– wake cycle regulation, cognitive impairment (including frontal executive dysfunction, memory retrieval deficits, dementia and hallucinosis), disorders of mood and affect, autonomic dysfunction (mainly orthostatic hypotension, urogenital dysfunction, constipation and hyperhidrosis), as well as sensory symptoms (most prominently hyposmia) and pain.⁴

Treatment strategies are focused on dopaminergic replacement therapy. Levodopa monotherapy may be successful in addressing motor symptoms in early-onset patients and may be optimized by adding on other dopamine-potentiating agents such as monoamine oxidase (MAO) inhibitors, dopamine agonists and catechol-O-methyl transferase (COMT) inhibitors. However, although these strategies can be efficacious in improving motor function, they are also associated with motor complications and fluctuations in ON and OFF time, which are often treatment resistant.^5,6

Safinamide is a new oral therapy that has recently been approved by the Drugs controller General (India) in 2019, USFDA in 2017 and European Medicines Agency (EMA) in 2014 for the treatment of adult patients with mid- to late-stage fluctuating disease as add-on therapy to a stable dose of levodopa alone or in combination with other PD treatments. Safinamide is a unique molecule with a novel mechanism of action. It is an α-aminoamide that has both dopaminergic and non-dopaminergic mechanisms of action.⁷

Safinamide has been evaluated in a comprehensive clinical study programme involving more than 3000 patients with mid- to late-stage PD, of whom more than 500 were treated for two years. Safinamide treatment was also effective for improving other motor complications (off-time, early morning akinesia), motor symptoms, non-motor symptoms, ADL and quality of life. Safinamide can be considered either as a first adjunct medication in Parkinson’s disease patients who are not sufficiently controlled on levodopa, and as an add-on in patients already taking levodopa and other concomitant dopaminergic medications.

Xafinact (Safinamide) tablets are marketed by Sun Pharmaceutical Industries Ltd. Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a retrospective, cross-sectional, observational survey to assess the real-life performance of Safinamide in early stage of Parkinson’s Disease patients.