FDA grants velusetrag with Fast Track designation

Velusetrag received the designation due to its ability to treat gastroparesis. | File image

Theravance Biopharma's velusetrag (TD-5108) has been granted Fast Track designation by the U.S. Food and Drug Administration.

Velusetrag received the designation due to its ability to treat symptoms linked to idiopathic and diabetic gastroparesis.

"We are pleased to receive Fast Track designation for the velusetrag development program in gastroparesis, given its potential to treat patients with this serious medical condition," Theravance Biopharma Chief Medical Officer Dr. Brett Haumann said. "Velusetrag represents a uniquely positioned asset as the only investigational drug to be examined in a study enrolling both idiopathic and diabetic gastroparesis patients. The valuable development and regulatory opportunities provided to the velusetrag program by Fast Track designation will augment our efforts to bring this important therapy to patients who currently have very few effective treatment options. We look forward to results from our Phase 2b study in mid-2017."

There are no treatment options for idiopathic gastroparesis that have been approved by the FDA and only one treatment option approved to combat diabetic gastroparesis. Patients with idiopathic gastroparesis experience delayed gastric emptying of food as well as nausea, vomiting, early satiety, pastprandial fullness and upper abdominal pain.

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Organizations in this story

Theravance Biopharma 901 Gateway Boulevard South San Francisco, CA 94080