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.

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.

12 Mar 2010

Study shows ghrelin prevents acute liver damage, reduces oxidative stress and inflammation

Spanish researchers determined that rats treated with recombinant ghrelin displayed a reduction in liver fibrosis. Ghrelin, a stomach hormone, reduced the amount of fibrogenic cells by 25% in the treated rodents. Research further showed ghrelin prevented acute liver damage and reduced oxidative stress and inflammation in the animal models.

1 Mar 2010

AGA conference highlights emerging technologies for digestive and metabolic disorders

The American Gastroenterological Association (AGA) is taking the lead in gastroenterological innovation by conducting "Fostering Innovation and Technology in Digestive and Metabolic Diseases."

24 Feb 2010

USAN approves generic name "ulimorelin" for Tranzyme Pharma's TZP-101

Tranzyme Pharma today announced that the United States Adopted Name Council (USAN) has approved the generic name “ulimorelin” for Tranzyme’s novel, late-stage, prokinetic agent TZP-101. Ulimorelin, if approved, is expected to be a first-in-class drug for the treatment of gastrointestinal (GI) dysmotility indications in acute care (hospital-based) settings.

27 Jan 2010

Research team reports rare etiology of SMA syndrome

Diabetes mellitus is one of the most common chronic disease of the world and the prevalence of diabetes mellitus is over 10% in Taiwan. Gastroparesis is reported in 5% to 12% of diabetic patients.

18 Jan 2010

Zassi Medical Evolutions forms new company to develop electrical stimulation technology

Zassi Medical Evolutions, a privately held organization that innovates, designs and develops high technology medical devices and software announced today that it has successfully spun out and formed a new company with Tucson, Arizona based Research Corporation Technologies (RCT) to pursue the continued development of a novel electrical stimulation technology for the gastrointestinal continence control market.

13 Jan 2010

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Elixir Pharmaceuticals, Inc. announced today that its partner, Siena Biotech S.p.A., has commenced Phase 1 clinical testing of Elixir’s potent, first-in-class SIRT1 (sirtuin-1) inhibitor for the treatment of Huntington’s Disease.

8 Jan 2010

Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Insurers under fire for denials of care, inadequate coverage

When people talk about revamping the health care system, among the often-mentioned reasons for change are unfair denials of care by insurance companies and medical debt, both of which are in the news today.

24 Nov 2009

FDA update on BYETTA injection: Amylin Pharmaceuticals and Eli Lilly respond

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection.

3 Nov 2009

FDA approves an expanded indication for BYETTA injection

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

31 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009