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Italy’s Newron files Parkinson’s drug with FDA

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SAFINAMIDE

 

cas  202825-46-5 (mesylate)

N2-{4-[(3-fluorobenzyl)oxy]benzyl}-L-alaninamide

Newron Pharmaceuticals and fellow Italy-headquartered partner Zambon have filed their investigational Parkinson’s disease treatment safinamide with regulators in the USA.

The submission to the US Food and Drug Administration is for safinamide as add-on therapy in early and mid-to late stage PD patients. Newron said the filing was based on “completion of activities agreed upon during meetings” with the FDA, noting that a marketing authorisation application was submitted to the European Medicines Agency in December.

Read more at: http://www.pharmatimes.com/Article/14-05-30/Italy_s_Newron_files_Parkinson_s_drug_with_FDA.aspx#ixzz33LlGLEt7

133865-89-1, Fce 26743, AC1L2ZLK, CHEMBL396778, MolPort-005-942-375,
Fce-26743, (S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)amino)propanamide
Molecular Formula: C17H19FN2O2   Molecular Weight: 302.343363

 

 

Safinamide (EMD 1195686) is a candidate drug against Parkinson’s disease with multiple methods of action.[1] In 2007, a Phase III clinical trial was started. It was scheduled to run until 2011.[2] The compound was originally discovered at Farmitalia-Carlo Erba and developed by Newron Pharmaceuticals, which sold the rights to Merck-Serono in 2006. In October 2011 Merck-Serono announced that they would give all rights to develop the compound back to Newron.[3]

Potential additional uses might be restless legs syndrome (RLS) and epilepsy.[4] They were being tested in Phase II trials in 2008, but no results are available.

 

Adverse effects

Common adverse events in clinical trials were nausea, dizziness, tiredness, headache and backache. There was no significant difference in the occurrence of these effects between safinamide and placebo treated patients.[5]

Methods of action

Parkinson and RLS relevant mechanisms

Safinamide is a reversible and selective monoamine oxidase B inhibitor, reducing degradation of dopamine, and a glutamate release inhibitor.[6][5] It also seems to inhibit dopamine reuptake.[7] Additionally, safinamide blocks sodium and calcium channels.[6]

References

  1.  Fariello, RG (2007). “Safinamide”. Neurotherapeutics 4 (1): 110–116. doi:10.1016/j.nurt.2006.11.011PMID 17199024.
  2.  Study of Safinamide in Early Parkinson’s Disease as Add-on to Dopamine Agonist (MOTION)
  3.  Merck Returns Rights for Safinamide to Newron, 21 October 2011.
  4.  Chazot, PL (2007). “Drug evaluation: Safinamide for the treatment of Parkinson’s disease, epilepsy and restless legs syndrome”. Current Opinion in Investigational Drugs 8 (7): 570–579. PMID 17659477.
  5.  H. Spreitzer (14 April 2014). “Neue Wirkstoffe – Safinamid”. Österreichische Apothekerzeitung (in German) (8/2014): 30.
  6.  Caccia, C; Maj, R; Calabresi, M; Maestroni, S; Faravelli, L; Curatolo, L; Salvati, P; Fariello, RG (2006). “Safinamide: From molecular targets to a new anti-Parkinson drug”. Neurology 67 (7 Suppl 2): S18–23. PMID 17030736.
  7.  Merck Serono: Vielversprechende Daten zur kognitiven Wirkung von Safinamid bei Parkinson im Frühstadium.(German) 8 June 2007.
1-13-2012
PHARMACEUTICAL COMPOSITION
10-12-2011
Pharmaceutical composition
10-22-2004
Methods of treating lower urinary tract disorders using sodium channell modulators
7-16-1999
ALPHA-AMINOAMIDE DERIVATIVES USEFUL AS ANALGESIC AGENTS

 


ANTHONY MELVIN CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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