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AstraZeneca ready to file constipation drug naloxegol

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File:Naloxegol.svg

4,5α-epoxy-6α-[(3,6,9,12,15,18,21-heptaoxadocosan-1-yl)oxy]-17-(prop-2-en-1-yl)morphinan-3,14-diol

Naloxegol (INN; NKTR-118), or PEGylated naloxol,[1] is a peripherally-selective opioid antagonist under development by AstraZeneca (licensed from Nektar) for the treatment of opioid-induced constipation.[2]

  1. Roland Seifert; Thomas Wieland; Raimund Mannhold; Hugo Kubinyi, Gerd Folkers (17 July 2006). G Protein-Coupled Receptors as Drug Targets: Analysis of Activation and Constitutive Activity. John Wiley & Sons. p. 227. ISBN 978-3-527-60695-5. Retrieved 14 May 2012.
  2. “Nektar | R&D Pipeline | Products in Development | CNS/Pain | Oral Naloxegol (NKTR-118) and Oral NKTR-119”. Retrieved 2012-05-14.

FEBRUARY 26, 2013

phase3

AstraZeneca has presented positive data from a late-stage trial of naloxegol in patients with non-cancer related pain and opioid-induced constipation.

In the fourth trial in a Phase III development programme designed to evaluate long-term safety and adverse event profile , 534 patients received naloxegol once-daily for up to 52 weeks, while 270 were on usual care (laxatives) for OIC. The most commonly-reported AEs occurring more frequently on naloxegol than on usual care included abdominal pain, diarrhoea, nausea and headache but the trial reported no imbalances in serious adverse events.

Briggs Morrison, head of the global medicines development at AstraZeneca, said “these high-level results are similar to the safety results seen in the Phase III studies previously reported and provide further confidence in the data we’ve seen to date for naloxegol”. The programme is now complete and filings in the USA and Europe are planned for the third quarter.

Globally, some 40–50% (28-35 million) of patients taking opioids for long-term pain develop constipation and about 40–50% (11-18 million) of those OIC sufferers achieve the desired outcomes with current options, ie laxatives.

The actual timing of the submissions depend in part on a meeting with the US Food and Drug Administration as naloxegol is currently considered a Schedule II controlled substance across the Atlantic based on its “structural relatedness” to noroxymorphone. AstraZeneca says it has conducted the studies necessary to evaluate the abuse potential and dependence-producing properties of naloxegol and a petition to de-control the drug was submitted in March 2012.

Naloxegol, a peripherally-acting mu-opioid receptor antagonist  and formerly known as NKTR-118, was licensed from Nektar Therapeutics in September 2009.


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DR ANTHONY 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 LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 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, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, 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 Open superstar 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 30 PLUS year tenure till date June 2021, Around 35 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, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, 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 33 lakh plus views on New Drug Approvals Blog in 233 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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