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.

Rhythm presents RM-131 Phase 1 clinical trial results for diabetic gastroparesis at ACG 2012

Rhythm announced today the results of two Phase 1 clinical trials of RM-131, the company's novel ghrelin agonist for the treatment of diabetic gastroparesis, which demonstrated that RM-131 greatly accelerates gastric emptying in healthy subjects with good tolerability.

22 Oct 2012

Amylin, Alkermes announce results from BYDUREON clinical study on type 2 diabetes

Amylin Pharmaceuticals, Inc. and Alkermes plc today announced results from the long-term extension of the DURATION-1 study, which showed that BYDUREON (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, was associated with clinically significant and sustained improvements in glycemic control during four years of treatment in adults with type 2 diabetes.

11 Jun 2012

European Commission grants marketing authorization for use of BYETTA with basal insulin

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced today that the European Commission has granted marketing authorization to BYETTA (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

23 Mar 2012

SK Biopharmaceuticals initiates YKP10811 phase 2 trial in chronic constipation

SK Biopharmaceuticals, a South Korean pharmaceutical company, announced today that the first patient was dosed in a phase 2 clinical trial in the US for patients suffering with chronic constipation using their new chemical entity YKP10811.

17 Mar 2012

BYETTA-basal insulin combination therapy receives EMA CHMP positive opinion

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion in the European Union for the expanded use of BYETTA (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

17 Feb 2012

New possibilities for relief from digestive diseases

As a researcher in neurogastroenterology for 40 years, professor Khalil Bitar has spent his professional life studying the causes of perplexing and what frequently become embarrassing problems for humans—issues such as constipation, diarrhea and colon disease.

17 Nov 2011

Amylin and Lilly terminate exenatide alliance, resolve litigation

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the companies.

9 Nov 2011

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

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 in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

New ways for treating diabetes

Surgeons at NewYork-Presbyterian Hospital/Columbia University Medical Center are innovating new ways to treat diabetes using techniques from weight-loss surgery, including experimental procedures to improve blood glucose levels and address a major complication of the disease.

16 Jul 2011

Exenatide tQT clinical trial meets pre-specified primary endpoint

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from a thorough QT (tQT) study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations.

8 Jul 2011

EC grants marketing authorization to BYDUREON for treatment of type 2 diabetes

Eli Lilly and Company, together with Amylin Pharmaceuticals, Inc. and Alkermes, Inc., announced today that the European Commission has granted marketing authorization to BYDUREON.

21 Jun 2011

Amylin to present data on investigational diabetes drug candidates at ADA annual meeting

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its two first-in-class diabetes drugs, BYETTA injection and SYMLIN injection, and its investigational diabetes drug candidates BYDUREON and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, CA from June 24 to June 28.

21 Jun 2011

Prior GID diagnosis impacts health outcomes of patients with Parkinson's

A new study investigating the incidence and impact of gastrointestinal disorders (GID) among patients with Parkinson's disease (PD) found that patients who received both a PD diagnosis and a prior GID diagnosis appeared to have worse health outcomes compared to patients who received a diagnosis for PD with no prior GID diagnosis.

16 Jun 2011

Amylin disappointed with U.S. District Court's ruling in BYETTA preliminary injunction

Amylin Pharmaceuticals, Inc. today issued the following statement regarding the decision of the United States District Court for the Southern District of California to deny its motion for a preliminary injunction to enjoin Eli Lilly and Company from engaging in anticompetitive activity and breaching its diabetes collaboration agreement with Amylin.

10 Jun 2011

U.S. District Court grants temporary restraining order in Amylin's litigation against Lilly

Amylin Pharmaceuticals, Inc. today announced that the United States District Court for the Southern District of California issued a temporary restraining order (TRO) against Eli Lilly and Company relating to its litigation with respect to the Amylin / Lilly diabetes collaboration agreement.

26 May 2011

Eli Lilly responds to Amylin's exenatide lawsuit

Eli Lilly and Company has provided additional perspective in response to Amylin Pharmaceuticals, Inc.'s lawsuit filed in the United States District Court for the Southern District of California.

17 May 2011

Amylin files lawsuit against Eli Lilly for improper commercialization of exenatide

Amylin Pharmaceuticals, Inc. today announced that it has filed a lawsuit against Eli Lilly and Company in the United States District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide.

16 May 2011

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

FDA clears Multi-Lead Trialing Cable for SCS therapy

Medtronic Inc., the leader in spinal cord stimulation for more than 25 years, today announced U.S. Food and Drug Administration (FDA) clearance and the global launch of the Multi-Lead Trialing Cable for use in the patient screening test for Medtronic spinal cord stimulation (SCS) therapy.

19 Nov 2010