AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication

... to seek approval for use in patients with peptic ulcer bleeding (PUB) following therapeutic endoscopy. ... is not possible or appropriate.(3) Peptic ulcer bleeding can be a life-threatening complication ... The NEXIUM(R) I.V. (esomeprazole sodium) Peptic ulcer Bleed study was a prospective multinational, ...

New Data Show High Frequency of Medical Claims for Gastrointestinal Events by Patients on Antiplatelet Therapy

... submitted at least one insurance claim for ulcer or gastrointestinal bleeding, according to data ... believe that multiple factors contribute to ulcer disease and its complications. Studies have shown ... Increasing age is a recognized risk factor for ulcer disease, and clopidogrel is commonly prescribed ...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections

... with diabetes will develop a lower extremity ulcer during the course of their disease. According to ... $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years ...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers

... with diabetes will develop a lower extremity ulcer during the course of their disease. According to ... $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years ...

Cardium and Tissue Repair Company's Excellarate Candidate for Healing Diabetic Wounds Gains Media Focus in Multiple Regions Across U.S.

... Type I or II diabetes with a non-healing foot ulcer present that have been present for at least six ... Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and ...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers

... with diabetes will develop a lower extremity ulcer during the course of their disease. According to ... $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years ...

Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain

... developing ulcers in the stomach or intestine and the risk of developing ulcer complications, such as bleeding. Patients at increased risk for ... developed either an endoscopically diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Patients received endoscopies at baseline ...

Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers

... include time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points. With ... included extensive photographic documentation, as well as computerized ulcer planimetry measurements on a weekly basis, represents one of the most ...

MEDIHONEY(TM) Dressings Shown to Help Improve Outcomes of Non-Healing Venous Leg Ulcers in Recent Case Series

... with odor (1) Roughly 1% of the population will have a venous leg ulcer at some point in their lifetime (2) The costs to treat venous leg ... the US exceeds $1 billion (3) (1) Charles H. Venous leg ulcer pain and its characteristics. Journal of Tissue Viability. ...

MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection

... that up to about 25% of persons with diabetes will develop a foot ulcer in their lifetime of which about 60% get infected. Diabetic foot ulcers ... increase the risk of foot ulcers. It usually takes several months for an ulcer to heal, and during this period there is a continual risk of foot ...

MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera

... that up to about 25% of persons with diabetes will develop a foot ulcer in their lifetime of which about 60% get infected. Diabetic foot ulcers ... increase the risk of foot ulcers. It usually takes several months for an ulcer to heal, and during this period there is a continual risk of foot ...

New Powder Speeds Healing of Difficult Foot Wounds

... acts very much like a layer of skin, is proving to speed the healing time and reduce the amount of pain that a patient suffering from a serious foot ulcer would normally experience. This includes open sores on the feet as a result of inflammatory bowel disease, diabetes or skin cancer. The study ...

Logical Therapeutics Appoints Peter A. Lankau as CEO and Director

... side effects, the most frequent being an increased rate of gastric and duodenal ulcers. In the United States alone, the direct costs of treating ulcer complications associated with NSAID use exceed $4 billion a year. Serious NSAID-induced gastrointestinal (GI) complications, such as hemorrhage and ...

AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

... - Company Also Submits sNDA for NEXIUM Capsules for Risk Reduction of Low-Dose Aspirin-Associated Peptic ulcer - WILMINGTON, Del., May 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN ) today announced the submission of a new drug application (NDA) ...

Clinician Reports Fast Healing of Intractable Wounds Using MEDIHONEY(R)

... Jason R. Hanft, DPM, Director of Medical Education at Baptist Health South Florida, revealed details of a recently concluded 11-patient venous leg ulcer (VLU) case series involving the use of Derma Sciences' MEDIHONEY(R). Dr. Hanft's presentation was part of the general agenda of the conference, ...

ULURU Inc. to Present Altrazeal(TM) Clinical Evidence and Advanced Therapeutic Research at the Diabetic Foot Global Conference (DFCon) 2009

... with Altrazeal(TM) following wound bed preparation. For all four patients, the time to healing was between one and four weeks and one patient's ulcer had been present in stasis for 24 weeks prior to Altrazeal(TM) treatment. Commenting on the results, Dr. Persich stated "Altrazeal(TM) represents a ...

Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints

... regulatory authorities in 2009." REDUCE-1 and REDUCE-2 Trial Design and Results The Registration Endoscopic Study to Determine ulcer Formation of HZT-501 Compared to Ibuprofen: Efficacy and Safety Study (REDUCE-1 and REDUCE-2) were two randomized, double-blind, controlled trials ...

Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting

... Rating Scale (GSRS) in patients with celiac disease. The GSRS is a validated measure used in clinical trials for irritable bowel syndrome and peptic ulcer disease. GSRS has been utilized in studies to assess larazotide acetate, including CLIN 1001-004 and CLIN 1001-006. Results from the poster ...

Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease

... symptoms. In the EU Tracleer(R) is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. Regulatory review for the inclusion of functional class II in the Tracleer(R) label is ongoing on a worldwide basis. Actelion also ...

PRoFESS(R) Results Announced at XVII European Stroke Conference

... doses of aspirin can increase bleeding time, which can adversely affect patients with bleeding disorders. Patients with a history of active peptic ulcer disease should avoid using aspirin, which can cause gastric mucosal irritation and bleeding. AGGRENOX should be avoided in the third trimester of ...

Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine

... inhibitors (SNRIs). NSAID-containing products, including Treximet, should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Treximet should not be used in late pregnancy because NSAID-containing products have been shown to cause ...

Northern California Foot and Ankle Center Santa Rosa Enrolling Patients With Chronic Diabetic Foot Ulcers for Matrix Clinical Research Trial

... administered once or twice over the course of the study. The primary endpoint will be the effect of Excellarate on the incidence of complete ulcer closure at 12 weeks or earlier. "The Excellarate topical gel using Gene Activated Matrix (GAM) technology is designed to provide localized and ...

Associated Foot & Ankle Specialists Enrolling Patients With Chronic Diabetic Foot Ulcers for MATRIX Clinical Trial

... safety and efficacy research study in which Excellarate is topically administered once or twice over the course of the study, with a goal of complete ulcer closure at 12 weeks or earlier. "The Excellarate topical gel, using Gene Activated Matrix (GAM) technology is designed to provide release of the ...

ActivBiotics Proposes Development Strategy for Its Novel Rifamycin Antibiotics

... therapy has been used as the treatment of choice for certain stubborn bacterial infections. Two prime examples are tuberculosis and gastric ulcer disease, caused by Mycobacterium tuberculosis infection and Helicobacter pylori infection, respectively. In both of these examples, the rifamycins ...

Aung FootHealth Clinics & Advanced Wound Care Center Enrolling Patients With Chronic Diabetic Foot Ulcers for Matrix Clinical Trial

... administered once or twice over the course of the study. The primary endpoint will be the effect of Excellarate on the incidence of complete ulcer closure at 12 weeks or earlier. "The Excellarate topical gel using Gene Activated Matrix (GAM) technology is designed to provide localized and ...

Derma Sciences to Enter Phase II Development of Wound Healing Product That May Use Body's Own Naturally Occurring Stem Cells

... safety in a Phase I study in humans. Through DSC127, Derma Sciences will be able to position itself as a key player in the very large diabetic foot ulcer and scar reduction markets, two rapidly growing and global segments of the wound care market. In the U.S. there are an estimated 2.4 million diabetic ...

Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis Trial in Japan

... improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in the placebo ... is, improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in Placebo group ...

Pozen Announces Positive Outcome for PA 325

... Furthermore, no ulcers were seen in the PA group, while 20 percent of subjects in the enteric coated aspirin 325mg group developed a gastric ulcer during the study. This difference was also statistically significant. Dr. John R. Plachetka, chairman, president and chief executive officer ...

POZEN Announces Positive Outcome for PA 325 Proof of Concept Study

... Furthermore, no ulcers were seen in the PA group, while 20 percent of subjects in the enteric coated aspirin 325mg group developed a gastric ulcer during the study. This difference was also statistically significant. Dr. John R. Plachetka, chairman, president and chief executive officer ...

Orapred ODT Tastes Good

... of latent diabetes mellitus); fluid and electrolyte disturbances (including fluid retention, hypertension); gastrointestinal (including peptic ulcer with possible perforation and hemorrhage); increased appetite; and weight gain. For additional safety information, please see full ...

Trexima (Sumatriptan/Naproxen Sodium) Superior Efficacy Data Published in JAMA

... nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing ...

Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Efficacy Across Multiple Migraine Attacks

... patients with asthma and nasal polyps in whom aspirin or other NSAIDs may induce an exacerbation of asthma. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing ...

Trexima (Sumatriptan/Naproxen Sodium) Provided Relief of Both Traditional and Non-traditional Migraine Symptoms

... nor in patients with asthma and nasal polyps in whom aspirin or other NSAIDs induce an exacerbation of asthma. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing ...

Major Manufacturer of Unapproved and Adulterated Drugs

... contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician. The ...

New Research Confirms the Benefit of Extended-Release Dipyridamole Plus ASA for Preventing Recurrent Stroke in Low- and High-Risk Patients

... in the gastric acidity. This is particularly beneficial for elderly stroke patients in whom reduced gastric acidity or gastric and duodenal ulcer therapy is widespread.5 Stroke is the third leading cause of death worldwide after heart disease and cancer.6 Patients who survive a first stroke ...

Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Migraine-Free Response Across Multiple Attacks

... nor in patients with asthma and nasal polyps in whom aspirin or other NSAIDs induce an exacerbation of asthma. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing ...

Prexige Study Shows Significantly Less Impact on Blood Pressure Than Ibuprofen in Osteoarthritis Patients with Controlled Hypertension

... of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: a randomized controlled trial. Lancet. 2004; 364(9435): 665-674. # # # Novartis Media Relations Corinne Hoff Irina Ferluga ...