Gastroparesis News and Research

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Gastroparesis, also called delayed gastric emptying, is a disorder in which the stomach takes too long to empty its contents. Normally, the stomach contracts to move food down into the small intestine for digestion. The vagus nerve controls the movement of food from the stomach through the digestive tract. Gastroparesis occurs when the vagus nerve is damaged and the muscles of the stomach and intestines do not work normally. Food then moves slowly or stops moving through the digestive tract.

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine and Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present preliminary TZP-102 Phase 2 data at this year's ACG annual meeting. The event is being held at the Henry B. Gonzalez Convention Center in San Antonio TX, October 15-20, 2010. Professor Wo is scheduled to speak on Wednesday, October 20th at 8:50am in Ballroom C1.

18 Oct 2010

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine, Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present ulimorelin Phase 2 data at this year's Joint International NGM Meeting on Saturday, August 28, 2010.

25 Aug 2010

Medtronic launches Defeat-HF clinical trial to evaluate SCS for heart failure

Medtronic, Inc. today announced the global launch of the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. It is the industry's first prospective, randomized study evaluating the clinical feasibility of spinal cord stimulation, or neurostimulation, to improve clinical signs and symptoms of heart failure.

30 Jul 2010

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

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

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Late-breaking Novo Nordisk extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose than Januvia plus metformin at 52 weeks.

28 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

Norgine to develop and commercialize Tranzyme's ulimorelin ghrelin agonist

Tranzyme Pharma, a clinical-stage biopharmaceutical company, and Norgine B.V., a European specialty pharmaceutical company, announced today that they have entered into a licensing agreement that provides Norgine with the exclusive rights to develop and commercialize Tranzyme's novel ghrelin agonist, ulimorelin (TZP-101), in Europe, Australia, New Zealand, the Middle East, South Africa and North Africa. Ulimorelin is entering Phase 3 development for the treatment of gastrointestinal dysmotility conditions in acute care settings.

16 Jun 2010

Tranzyme Pharma to present data on prokinetic agent TZP-101 in GI recovery at ASCRS 2010

Tranzyme Pharma today announced that Philippa Charlton, MD, Tranzyme's Medical Director, and her colleagues G. Bochicchio, J.C. Pezullo, G. Kosutic, and A. Senagore, will present a poster entitled "The Prokinetic Agent TZP-101 (a Ghrelin Agonist) Accelerates GI Recovery in Partial Colectomy Patients Independently of Total Opioid Use and Type of Surgery" at the upcoming 2010 Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons (ASCRS; Minneapolis, May 15-19).

17 May 2010

Medtronic initiates U.S. clinical trial of RestoreSensor neurostimulator in chronic pain patients

Medtronic, Inc. today announced the initiation of a prospective, multi-center, randomized U.S. clinical trial for the RestoreSensorTM neurostimulator that adapts therapy to the changing needs of chronic pain patients by responding automatically to changes in body position and activity in an upright position.

7 May 2010

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

6 May 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Pacemaker in stomach can help treat severe stomach disorders and chronic vomiting

People with severe stomach disorders can sometimes suffer from chronic vomiting. This symptom can be treated with electrical impulses from a pacemaker in the stomach. A new method enables patients who could benefit from this treatment to be identified, and electrical stimulation leads to reduced nausea and fewer days in hospital, shows a study from the Sahlgrenska Academy at the University of Gothenburg, Sweden.

29 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

Tranzyme Pharma's ulimorelin Phase 2 trial data selected for presentation at DDW 2010

Tranzyme Pharma announced today that data from the Phase 2 clinical trial of ulimorelin (TZP-101) for the treatment of severe gastroparesis have been selected for an oral presentation at Digestive Disease Week (DDW) 2010 being held May 1-5, 2010 in New Orleans, LA.

12 Mar 2010

Ipsen grants Rhythm exclusive global license for melanocortin and ghrelin programs

Ipsen, a global biotechnology specialty care group, and Rhythm Pharmaceuticals, a biotechnology company developing peptide therapeutics for metabolic diseases, announced today that they have concluded a license agreement for Ipsen’s proprietary peptide therapeutics targeting obesity, metabolic diseases, and gastrointestinal disorders.