E-Newsletter • August 2022 |
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Editor's E-Note
Effective treatments for gastroparesis—the delayed gastric emptying of solid food not caused by a mechanical obstruction—are greatly needed to reduce mortality and improve quality of life. There’s only one pharmaceutical treatment for the disorder, and it’s approved only for diabetic gastroparesis, not other types. Processa Pharmaceuticals is conducting a Phase 2 clinical trial of a “highly selective 5-hydroxytryptamine-4 receptor agonist.”
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— Kate Jackson, editor |
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In This E-Newsletter
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A Phase 2 Clinical Trial of a Drug for Gastroparesis
Processa Pharmaceuticals, a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need, recently announced that it has enrolled its first patient in the Phase 2A clinical trial of PCS12852 in patients with moderate to severe gastroparesis. Gastroparesis is a chronic gastric motility disorder in which the stomach does not empty food as quickly as it should, resulting in potentially serious forms of heartburn, nausea, vomiting, and bloating for millions of patients in the United States. As such gastroparesis is recognized to be a serious unmet medical need condition for which patients need alternative treatment options.
Currently, the only FDA-approved pharmaceutical treatment for gastroparesis is metoclopramide, a dopamine D2 receptor antagonist, which is approved only for diabetic gastroparesis, not for other subsets of gastroparesis. Additionally, it carries a black box warning, limiting use for this chronic disorder to less than 12 weeks due to potentially serious side effects.
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