Dyspepsia News and Research

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Indigestion, known as ''upset stomach'' or ''dyspepsia'', meaning hard or difficult digestion, is a medical condition characterized by chronic or recurrent pain in the upper abdomen, upper abdominal fullness and feeling full earlier than expected when eating. It can be accompanied by bloating, belching, nausea, or heartburn.

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Covidien, a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).

10 Nov 2010

Acton submits Manufacturing Supplement to FDA for AEROSPAN Inhalation Aerosol

Acton Pharmaceuticals, Inc. today announced that it has submitted to the U.S. Food and Drug Administration (FDA), a Manufacturing Supplement to the previously approved AEROSPAN Inhalation Aerosol NDA.

4 Nov 2010

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

Hyperion Therapeutics, Inc. today announced that the Company's phase III pivotal study of glycerol phenylbutyrate (HPN-100), an investigational drug for the treatment of urea cycle disorders (UCDs), met its primary endpoint. The non-inferiority study, conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA) in June 2009, evaluated the ammonia control of glycerol phenylbutyrate as compared to sodium phenylbutyrate (BUPHENYL®).

3 Nov 2010

Boehringer Ingelheim announces availability of PRADAXA in U.S. pharmacies

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that its new oral anticoagulant, Pradaxa® (dabigatran etexilate mesylate) 150mg capsules, will be available starting Wednesday by prescription in pharmacies across the United States, including CVS/pharmacy, Rite Aid, Walmart, Target, Kmart® and The Kroger Co. In addition, leading independents under the Health Mart®, Good Neighbor Pharmacy® and Medicine Shoppe® banners will be stocked.

2 Nov 2010

Health Canada approves PRADAX anticoagulant for stroke prevention in AF patients

Boehringer Ingelheim Ltd. today announces that Health Canada has granted approval of PRADAX (dabigatran etexilate), an oral anticoagulant for the prevention of stroke and systemic embolism in adults with atrial fibrillation in whom anticoagulation is appropriate. PRADAX is the first innovative drug approved in Canada in more than two decades to reduce the risk of stroke in Canadians with atrial fibrillation.

28 Oct 2010

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010

Pradaxa capsules receive FDA approval for reducing stroke and systemic embolism risk in AFib patients

The U.S. Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate) capsules to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).

20 Oct 2010

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

20 Oct 2010

ACG 75th Scientific Meeting to review advances in gastrointestinal research, treatment of digestive diseases

Many of the world's preeminent gastroenterologists will gather for the American College of Gastroenterology's (ACG) 75th Annual Scientific Meeting at the Henry B. Gonzalez Convention Center in San Antonio, Texas starting Monday October 18, 2010, to review the latest scientific advances in gastrointestinal research, treatment of digestive diseases and clinical practice management.

19 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Studies explore impact of upper GI conditions on sleep

The impact of upper GI conditions, like gastroesophageal reflux disease (GERD) and functional dyspepsia, on sleep—and treatments aimed at providing relief to heartburn/acid reflux patients who suffer from disordered sleep—were explored in three new studies related to sleep dysfunction presented today at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, Texas.

18 Oct 2010

Acorda presents new analysis of AMPYRA tablets at ECTRIMS Congress

Acorda Therapeutics, Inc. today announced that a new analysis of AMPYRA (dalfampridine) Extended Release Tablets, 10 mg data examining walking improvement in treatment responders has been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

15 Oct 2010

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.

28 Sep 2010

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

ViroPharma Incorporated today announced the presentation of data from its Phase 1 study of VP20621 (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections, a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications.

16 Sep 2010

Study: IV ibuprofen decreases pain, morphine use in pre and post-operative orthopedic surgery patients

Cumberland Pharmaceuticals Inc. today announced the publication of new data supporting the safety and efficacy of Caldolor® (ibuprofen) Injection in pre and post-operative orthopedic surgery patients. The study, which was published in the August edition of the peer-reviewed journal Pain Medicine, concludes that IV ibuprofen significantly decreased pain and morphine use when compared with placebo.

31 Aug 2010

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

Pfizer Inc. announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC).

24 Aug 2010

US WorldMeds announces acquisition of Solstice Neurosciences for $35M

US WorldMeds, LLC, a Kentucky-based specialty pharmaceutical company that develops unique products to address unmet medical needs, today announced it has acquired Solstice Neurosciences, Inc. for $35 million. The acquisition expands US WorldMeds' operations, adds to the company's growing portfolio of products and enhances the company's ability to create and deliver high-quality specialty pharmaceutical products to its targeted global markets.

16 Aug 2010

Genzyme accepts CMS decision for delaying Renvela administration to dialysis patients

Genzyme Corp.today said it welcomed the Centers for Medicare and Medicaid Services' decision not to include oral medications without IV equivalents in Medicare's End Stage Renal Disease patient benefit. According to the final rule, these medications, including Genzyme's Renvela (sevelamer carbonate), will not be included in the bundle until January 1, 2014.

28 Jul 2010

Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

New long term data showed that Vimpat- (lacosamide) C-V provided sustained reduction in seizure frequency for up to five years when used as an add-on treatment for uncontrolled partial onset seizures in adults with epilepsy. In addition post-hoc exploratory analyses showed that adjunctive lacosamide treatment reduced partial-onset seizure frequency and improved responder rates when added to a broad range of antiepileptic drugs (AEDs) including both traditional sodium channel-blocking agents and those that act on non-sodium channel-targets.

30 Jun 2010

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Tranzyme Pharma announced positive top-line results today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis, a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested were effective, safe and well tolerated.

29 Jun 2010