Safinamide significantly improves Quality of Life (QoL) in early and advanced Parkinson?s disease (PD) patients
Safinamide filing for regulatory approval as add-on in early and mid-to late PD patients in EU and US expected in Q4/2013
MILAN, Italy I April 22, 2013 I Newron Pharmaceuticals S.p.A. (?Newron?), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, presented results from Phase III studies with safinamide at the 9th International Congress on Mental Dysfunction & Other Non-Motor Features in Parkinson?s Disease and Related Disorders, on April 20, 2013.
Statistically significant improvement in Quality of Life, as assessed by the Parkinson?s disease Quality of Life (PDQ-39) and/or the European Quality of Life (EuroQoL, EQ-5D) scales has been associated with short term (six months), and long term (eighteen to twenty four months) treatment with safinamide.
In patients with early PD on a single dopamine agonist, safinamide 100mg/day was associated with significant improvement in PDQ-39 (p=0.03) and EQ-5D (p=0.005) after six months (MOTION study), while in studies 015/017, a statistically significant benefit of safinamide 50-100mg/day on EuroQoL (EQ-5D) was noted at 18 months of treatment (p=0.008), all compared to dopamine agonist monotherapy (placebo).
Patients with moderate to severe PD with motor fluctuations stabilized on levodopa and other dopaminergic treatments (standard of care) experienced statistically significant improvement in PDQ-39 after six (p=0.036) and twenty four months (p=0.019) of treatment with 100mg/day of safinamide (study 016/018), compared to standard of care (placebo). In the SETTLE study, safinamide at a dose of 50-100 mg/day was associated with a statistically significant improvement in PDQ-39 (p=0.006) and EQ-5D (p<0.001) at six months, compared to standard of care (placebo).
?Previously reported results have established that safinamide treatment improves motor symptoms and activities of daily living in early PD patients, while in patients with motor fluctuations (advanced PD patients), safinamide benefits ON-time, OFF-time and motor symptoms. The significant improvements in Quality of Life as perceived by the patient during short and long term treatment clearly indicate the clinical relevance of safinamide?s benefits on symptoms of PD,? said Ravi Anand, Newron?s CMO.
?The statistically and clinically improvements in quality of life demonstrated in both early and late stage patients maintained in the long term confirm the unique efficacy profile of Safinamide that is able to provide significant improvements both in motor and non-motor functions of PD patients and represent also an important driver for patients? compliance and disease management costs? said Marco Sardina, Zambon?s CSO.
The abstract presented at the MDPD is available for download at: http://www.newron.com/ENG/Default.aspx?SEZ=5&PAG=122 and http://www.zambonpharma.com
About safinamide
Safinamide, an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson?s disease (PD). It is believed to have both dopaminergic and non dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Based on the phase III results of safinamide for treatment of Parkinson?s disease, Newron is working to expedite the global filing of the compound, together with its partners. Zambon Group has the rights to commercialise safinamide globally, excluding Japan and other key Asian territories, and Meiji Seika has the rights to develop and commercialise safinamide in Japan and other key Asian territories. Newron?s additional projects are primarily addressed towards highly promising treatments for rare diseases and are at various stages of preclinical and clinical development, including sNN0031 for Parkinson?s disease, sarizotan for Rett?s syndrome, sNN0029 for ALS, ralfinamide for specific pain indications, and NW-3509 as potential first add-on therapy for the treatment of schizophrenia. www.newron.com
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 BPCO and on the CNS therapeutic area with safinamide for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. For details on Zambon please see: www.zambongroup.com
SOURCE: Newron
Post Views: 235
Safinamide significantly improves Quality of Life (QoL) in early and advanced Parkinson?s disease (PD) patients
Safinamide filing for regulatory approval as add-on in early and mid-to late PD patients in EU and US expected in Q4/2013
MILAN, Italy I April 22, 2013 I Newron Pharmaceuticals S.p.A. (?Newron?), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, presented results from Phase III studies with safinamide at the 9th International Congress on Mental Dysfunction & Other Non-Motor Features in Parkinson?s Disease and Related Disorders, on April 20, 2013.
Statistically significant improvement in Quality of Life, as assessed by the Parkinson?s disease Quality of Life (PDQ-39) and/or the European Quality of Life (EuroQoL, EQ-5D) scales has been associated with short term (six months), and long term (eighteen to twenty four months) treatment with safinamide.
In patients with early PD on a single dopamine agonist, safinamide 100mg/day was associated with significant improvement in PDQ-39 (p=0.03) and EQ-5D (p=0.005) after six months (MOTION study), while in studies 015/017, a statistically significant benefit of safinamide 50-100mg/day on EuroQoL (EQ-5D) was noted at 18 months of treatment (p=0.008), all compared to dopamine agonist monotherapy (placebo).
Patients with moderate to severe PD with motor fluctuations stabilized on levodopa and other dopaminergic treatments (standard of care) experienced statistically significant improvement in PDQ-39 after six (p=0.036) and twenty four months (p=0.019) of treatment with 100mg/day of safinamide (study 016/018), compared to standard of care (placebo). In the SETTLE study, safinamide at a dose of 50-100 mg/day was associated with a statistically significant improvement in PDQ-39 (p=0.006) and EQ-5D (p<0.001) at six months, compared to standard of care (placebo).
?Previously reported results have established that safinamide treatment improves motor symptoms and activities of daily living in early PD patients, while in patients with motor fluctuations (advanced PD patients), safinamide benefits ON-time, OFF-time and motor symptoms. The significant improvements in Quality of Life as perceived by the patient during short and long term treatment clearly indicate the clinical relevance of safinamide?s benefits on symptoms of PD,? said Ravi Anand, Newron?s CMO.
?The statistically and clinically improvements in quality of life demonstrated in both early and late stage patients maintained in the long term confirm the unique efficacy profile of Safinamide that is able to provide significant improvements both in motor and non-motor functions of PD patients and represent also an important driver for patients? compliance and disease management costs? said Marco Sardina, Zambon?s CSO.
The abstract presented at the MDPD is available for download at: http://www.newron.com/ENG/Default.aspx?SEZ=5&PAG=122 and http://www.zambonpharma.com
About safinamide
Safinamide, an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson?s disease (PD). It is believed to have both dopaminergic and non dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Based on the phase III results of safinamide for treatment of Parkinson?s disease, Newron is working to expedite the global filing of the compound, together with its partners. Zambon Group has the rights to commercialise safinamide globally, excluding Japan and other key Asian territories, and Meiji Seika has the rights to develop and commercialise safinamide in Japan and other key Asian territories. Newron?s additional projects are primarily addressed towards highly promising treatments for rare diseases and are at various stages of preclinical and clinical development, including sNN0031 for Parkinson?s disease, sarizotan for Rett?s syndrome, sNN0029 for ALS, ralfinamide for specific pain indications, and NW-3509 as potential first add-on therapy for the treatment of schizophrenia. www.newron.com
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 BPCO and on the CNS therapeutic area with safinamide for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. For details on Zambon please see: www.zambongroup.com
SOURCE: Newron
Post Views: 235
