Indomethacin News and Research

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FDA accepts Iroko's submicron indomethacin NDA for treatment of acute pain in adults

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to scientific advancements in analgesia, announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for lower dose submicron indomethacin, a non-steroidal anti-inflammatory drug, for the proposed indication of treatment of mild to moderate acute pain in adults.

16 Jul 2013

Caution on COX inhibitor use in preterm infants

Very-low-birthweight preterm infants with thrombocytopenia treated with cyclooxygenase inhibitors are at an increased risk for intracerebral hemorrhage, particularly if they have decreased platelet levels, research shows.

5 Feb 2013

Iroko’s submicron indomethacin Phase 3 study on post-surgical acute pain meets primary endpoint

Iroko Pharmaceuticals, LLC today announced that the Phase 3 study evaluating the company's investigational, lower dose submicron indomethacin in post-surgical acute pain met its primary endpoint of demonstrating significant pain relief compared with placebo.

10 Dec 2012

Topical NSAIDs as effective as oral NSAIDs for knee, hand arthritis

For those suffering from osteoarthritis of the knees or hands, applying topical non-steroidal anti-inflammatory drugs (NSAIDs) — in the form of creams, gels and patches — can bring weeks of pain relief, finds a new review by The Cochrane Library.

21 Sep 2012

Cobiprostone shows promise against NSAID-induced gastric mucosal injury

Sucampo Pharmaceuticals, Inc. today announced the presentation of preclinical data at Digestive Disease Week 2012, in San Diego, which demonstrates the protective effect of cobiprostone against epithelial barrier dysfunction in models of non-steroidal anti-inflammatory drug (NSAID)-induced gastric mucosal injury.

21 May 2012

Indomethacin given after digestive diagnostic procedure may prevent pancreatitis: Study

There is a high risk of pancreatitis after a diagnostic procedure - ERCP (endoscopic retrograde cholangiopancreatography). ERCP is a procedure that is commonly utilized to treat or diagnose problems of the bile and pancreatic ducts. During an ERCP procedure, a lighted scope is inserted through the mouth while X-ray pictures are taken to check the tubes that drain the liver, pancreas and gallbladder.

15 Apr 2012

First clinical trial to clearly demonstrate effective prevention of post-ERCP pancreatitis

A study in the current issue of the New England Journal of Medicine shows a serious complication of ERCP, a procedure commonly used to diagnose and treat problems of the bile and pancreatic ducts, may be eliminated with a single dose medication.

12 Apr 2012

Lee's Pharma licenses rights to commercialize PL2200 Aspirin in China

PLx Pharma Inc, a Houston based pharmaceutical company developing gastrointestinal (GI) safer drugs has licensed to Lee's Pharmaceutical Holdings Limited (Lee's Pharma) the rights to register and commercialize in China, Hong Kong and Macau the PL2200 Aspirin, a GI safer aspirin product currently in development in the US, for prevention of cardiovascular diseases. Cardiovascular is one of the focus areas of Lee's Pharma.

10 Apr 2012

UTHealth, PLx Pharma to test phosphatidylcholine-enriched version of indomethacin in PDA model

PLx Pharma Inc, a Houston-based pharmaceutical company developing a medical discovery made at The University of Texas Health Science Center at Houston (UTHealth) Medical School, has been awarded $565,449 for the first year of a potential two-year $1,118,398 grant to conduct research designed to enhance a treatment for premature babies with a common congenital heart defect.

29 Mar 2012

Results of Phase 2 program to develop NSAIDs to be reported at ACR annual meeting

The results of the Phase 2 program sponsored by Iroko Pharmaceuticals to develop novel, lower-dose formulations of a widely used class of pain medicines will be reported November 7th at the annual meeting of the American College of Rheumatology in Chicago.

5 Nov 2011

First COX-2-targeted PET imaging agent for use in animal models of inflammation, cancer

A series of novel imaging agents could make it possible to "see" tumors in their earliest stages, before they turn deadly.

10 Oct 2011

Nano-formulated indomethacin at lower dose effective in treating pain

A novel, lower-dose formulation of indomethacin, a widely used pain reliever, is absorbed faster by the body than a standard formulation and maintains comparable maximum concentrations in the blood despite being administered at a lower dose, according to a study to be reported here tomorrow at the annual meeting of the American Headache Society.

4 Jun 2011

USPTO issues Notice of Allowance to AlphaRx ARX8203 pain product candidate

AlphaRx Inc. has received a Notice of Allowance from the United States Patent and Trademark Office for its lead pain product candidate code named ARX8203, a potentially safer drug intended for pain treatment.

25 Mar 2011

FDA approves Amneal's Indomethacin ER capsules

Amneal Pharmaceuticals, LLC is pleased to announce that it received U.S. FDA approval for Indomethacin Extended Release capsules, USP in the 75 mg strength effective December 1, 2010.

3 Mar 2011

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

AlphaRx regains all rights to Indaflex from Cypress Bioscience

AlphaRx, Inc. today announced that it has entered into an agreement with Cypress Bioscience, under which AlphaRx is regaining all rights to Indaflex(TM) from Cypress Bioscience, which AlphaRx had previously licensed to Proprius Pharmaceuticals, which was subsequently acquired by Cypress Bioscience.

29 Jun 2010

Nuon study confirms potential utility of tranilast as uricosuric agent

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that results from clinical and preclinical studies demonstrating the ability of tranilast to reduce serum uric acid levels and monosodium urate crystal-induced inflammation - two important risk factors for gout - were presented at The European League Against Rheumatism (EULAR) 2010 Annual European Congress of Rheumatology in Rome, Italy, June 16-19, 2010.

22 Jun 2010

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Regeneron Pharmaceuticals, Inc. announced that a Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that ARCALYST (rilonacept), also known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

9 Jun 2010

NIH awards PLx Pharma multiple grants for development of GI safer NSAIDs

PLx Pharma, a pharmaceutical company developing safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs), today announced that it has been awarded multiple grants from the National Institutes of Health (NIH) totaling approximately $2,000,000. This funding has been awarded to support further advancement of a range of products currently under development by PLx.

12 May 2010

Sucampo Pharmaceuticals presents Phase 2 cobiprostone clinical trial data at DDW 2010

Sucampo Pharmaceuticals, Inc. today presented results of a phase 2 clinical trial of cobiprostone, an investigational drug, for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). These data were presented at the Digestive Disease Week (DDW) 2010 conference in New Orleans, Louisiana, as part of the distinguished abstract plenary session.

4 May 2010