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NDA PA32540, Pozen Submits NDA for Aspirin Alternatives



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PA-325/40 (EC-ASA 325 mg + IR omeprazole 40 mg)

enteric-coated aspirin (EC-ASA) 325 mg

MAR 27,2013

Pozen Inc. announced the submission of a new drug application to the U.S. Food and Drug Administration for the marketing approval of two potential cardiovascular drugs.

The move is a major step toward commercializing the drugs and means that the company thinks it has proven that the drugs are safe and effective.

Pozen’s PA32540 and PA8140 are both intended as alternatives to plain aspirin for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers.

Pozen’s drugs contain aspirin and the omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.

Pozen is seeking approval for use in patients at risk of aspirin-induced ulcers.

Pozen CEO John Plachetka called the move “an important milestone for the drug” and said the company looks forward to completing a commercial deal with a partner “in the upcoming months.”

Pozen’s PA-325/40 is a combination pill containing enteric-coated aspirin 325 mg surrounded by a pH-sensitive film surrounded by an immediate-release omeprazole 40 mg.

Pozen designed the drug for patients requiring daily aspirin for secondary cardiovascular prophylaxis who are at risk for aspirin-associated gastric ulceration. Low-dose aspirin (ASA) is recommended for the secondary prevention of cardiovascular  and cerebrovascular events. However, daily aspirin therapy is associated with adverse gastrointestinal events, including gastric ulceration and bleeding, as well as dyspepsia and GERD-like symptoms  which may limit the patient compliance and continued use . Proton-pump inhibitors, like omeprazole, are recommended to reduce the risk of upper gastrointestinal injury in patients at risk for potentially harmful events associated with chronic daily aspirin use, including dyspepsia and GERD

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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, 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...... , 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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