Zambon Announces Enrollment of First Patient in the Synapses Study (Drug Utilization Study N. Z7219N02)

MILAN, October 18, 2016 /PRNewswire/ --





Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area today announced that the first patient has been enrolled in the SYNAPSES Study, a European multicentre retrospective-prospective cohort study to observe safinamide safety and pattern of use in clinical practice in Parkinson's disease (PD) patients during the first post-commercialization phase.

(Logo:  http://photos.prnewswire.com/prnh/20150515/744259 )



Parkinson's disease is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer's disease, affecting 1-2% of individuals aged greater than or equal to 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. Safinamide represents a new treatment option for patients with PD already treated with L-dopa alone or with other therapeutic combinations. Its dopaminergic and non-dopaminergic properties introduce a novelty within the drugs for PD treatment.

"We are pleased to enrol the first patient in the SYNAPSES Study, which will further our understanding of the risk/benefit profile of safinamide in Parkinson's patients, in particular in patients aged > 75 years and patients suffering from relevant concomitant conditions" declares Charlotte Keywood, Open R&D Global Head Zambon SpA.

About the SYNAPSES Study  

This multicentre retrospective-prospective cohort observational study is planning to enrol at least 1.600 patients in 140 centres in Europe for the duration of 36 months.

Study participants are patients who start treatment with safinamide at enrolment visit or in the previous 4 months, according to clinical practice after its commercialization.

The primary endpoint for the study will be to describe the safety profile of safinamide in real-life conditions during 1 year in the first post-commercialization phase (overall and subgroup analysis - patients aged >75 years, patients with concomitant psychiatric conditions specifically pyschosis, bipolar disorder, severe depression).

About Xadago(R) (safinamide)  

Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24 month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon has the rights to develop and commercialize Xadago(R) globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound. The rights to develop and commercialize Xadago(R) in the USA have been granted to US WorldMeds, by Zambon.

References:

Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. [http://www.ncbi.nlm.nih.gov/pubmed/25044402 ]  Borgohain, Rupam;  Szasz, Jozsef;  Stanzione, Paolo;  Meshram, Chandrashekhar;  Bhatt, Mohit H et al. (2014) Movement disorders : official journal of the Movement Disorder Society vol. 29 (10) p. 1273-80.

Anand R: Safinamide is associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa (SETTLE). 17th International Congress of Parkinson's Disease and Movement Disorders, Sydney, Australia, June 16-20, 2013.

About Parkinson's disease  

PD is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer's disease, affecting 1-2% of individuals aged greater than or equal to 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on L-dopa. L-dopa remains as the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the "off-time" effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms.

References:

BMC Oertel. European Handbook of Neurological Management, Vol1, Chapter 14 & 15, 2011.

NICE PD guideline, 2006.

About Zambon   

Zambon is a leading Italian pharmaceutical and fine-chemical multinational company that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and woman care, and is very strongly committed to its entry into the CNS space. Zambon SpA produces high quality products thanks to the management of the whole production chain which involves Zach (Zambon chemical), a privileged partner for API, custom synthesis and generic products. The Group is strongly working on the treatment of the chronic respiratory diseases as asthma and BPCO and on the CNS therapeutic area with Xadago(R) (safinamide) for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 19 countries with subsidiaries and almost 2,800 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 84 countries.

For details on Zambon please see: http://www.zambongroup.com.

Further Information: Media, Zambon, Luca Primavera - CCO, Phone: +39-02-66524491, Mobile: +39-335-7247417, Email: luca.primavera@zambongroup.com, Italy, Milva Naguib, Phone: +39-02-66524095, Mobile: +39-3459215675, Email: milva.naguib@zambongroup.com



Photo:
http://photos.prnewswire.com/prnh/20150515/744259 




Zambon S.p.A.

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