Symptoms of gastroparesis
can be similar to those that occur in other conditions," said Norton.
In addition, Tranzyme is developing TZP-102, an oral ghrelin agonist which is in Phase 2 trials for the out-patient treatment of gastroparesis
and other chronic GI and motility disorders, including GERD, functional dyspepsia, OBD and IBS-C.
Patients with moderate to severe diabetic gastroparesis
experience significant debility.
METOZOLV ODT is the first available treatment for both diabetic gastroparesis
and symptomatic documented GERD that offers physicians and patients the similar safety and efficacy of metoclopramide with the added convenience of an orally disintegrating tablet formulation," said Ronnie Fass, MD, FACP, FACG and Professor of Internal Medicine at the University of Arizona.
Rhythm is developing the ghrelin peptide agonist, RM-131, for the treatment of diabetic gastroparesis
and other GI functional disorders; and the MC4R peptide agonist, RM-493, for obesity and diabetes.
In their approval letter, the FDA noted there are limited treatment options for diabetic gastroparesis
and agents currently available have serious side effects.
Also called delayed gastric emptying, gastroparesis
is a condition where the movement of food out of the stomach is impaired.
TZP-102 is in clinical development for gastroparesis
and has the potential to treat other chronic GI and motility disorders, including GERD, functional dyspepsia, opioid bowel dysfunction and irritable bowel syndrome with constipation.
The current approved drug available in the United States for treating diabetic gastroparesis
symptoms is metoclopramide, which suffers from a black box warning for tardive dyskinesia and is limited to acute use.
TZP-102's effects on symptom severity were evaluated by a validated patient-reported outcome (PRO) instrument, the Patient Assessment of Gastrointestinal Symptoms scale (PAGI-SYM), and the Gastroparesis
Cardinal Symptom Index (GCSI) after 8, 15, and 28 days of treatment.
which is developing relamorelin (RM-131), a peptide ghrelin agonist, for the treatment of diabetic gastroparesis
and other GI functional disorders.
In a previous study, subjects with gastroparesis
were found to have high levels of hydrogen in their breath 12 hours after eating a test meal containing potato starch and lactulose.