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The FDA Fast-tracked Velusetrag May Be a Safer Long-term Treatment for Gastroparesis

In This Article

  • Velusetrag is a 5-hydroxytryptamine receptor 4 agonist that has no affinity for other receptor types
  • The high selectivity of velusetrag makes it safer than other treatments for gastroparesis, many of which have cardiac side effects that are linked to neurological issues
  • At the end of a 12-week study, normalization of gastric emptying was achieved in 44%, 65% and 71% of participants taking velusetrag, varying based on dosage

Velusetrag, an oral, highly selective 5-hydroxytryptamine receptor 4 agonist, may provide unprecedented, long-term treatment for patients with diabetic or idiopathic gastroparesis.

Braden Kuo, MD, of the Digestive Healthcare Center at Massachusetts General Hospital presented new research at Digestive Disease Week in San Diego that explains that velusetrag can be safer than many prokinetic agents used to treat gastroparesis. While other agents can relieve symptoms in patients with the disease, many of them have cardiac side effects that are linked to neurological issues.

Dr. Kuo said that velusetrag stands to be a more effective long-term treatment, as the agonist is uniquely potent and has no affinity for other receptor types, including the 5-HT, the 5-HT2 or 5-HT3 and other dopamine receptors. The oral drug received Fast Track designation from the FDA in 2016.

These findings are the result of a study composed of 232 patients with delayed gastric emptying and gastroparesis symptoms. Over a 12-week span, participants received either 5 mg, 15 mg or 30 mg doses of velusetrag, with some participants receiving only a placebo.

By the end of the 12-week period, researchers found that 44% of patients in the 5 mg group, 65% of patients in the 15 mg group and 71% of patients in the 30mg group achieved normalization of gastric emptying. In the placebo group, zero patients achieved these results.

Kuo said that the findings of this study will provide context for the next phase of studies of velusetrag, which will focus on the optimal dosing of the agent in patients with gastroparesis.

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