The recent first global approval of plecanatide has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.
Late January 2017, plecanatide (Trulance™), developed by Synergy Pharmaceuticals, received its first global approval in the USA for the treatment of adult patients with chronic idiopathic constipation (CIC). Plecanatide is an oral guanylate cyclase-C (GC-C) agonist that regulates ion and fluid transport in the gastrointestinal tract.
CIC affects at least 33 million Americans and an estimated 14% of the global population.1 Although several agents are available for the treatment of CIC, including the first in class GC-C agonist linaclotide2 (indicated for the treatment of CIC and irritable bowel syndrome with constipation [IBS-C]), challenges associated with inter-individual efficacy, tolerability and patient satisfaction necessitate the development of new treatment options.
Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research said:
“No one medication works for all patients suffering from chronic gastrointestinal disorders”.
“With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”3
Quoted in a Synergy press release4 William D. Chey, M.D., Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan commented in relation to the approval:
“TRULANCE presents an exciting new treatment option for patients with chronic constipation. Its efficacy and safety profile, plus its negligible systemic absorption, are attractive attributes that make it a welcome addition to our treatment options.”
Plecanatide is also undergoing phase III investigation in IBS-C. The label for plecanatide contains a black-box warning involving the risk of dehydration in paediatric patients for whom the safety and effectiveness of the drug have not been established.