New Indication for Trulance
January 25, 2018 – The U.S. FDA has approved a new indication for Trulance® (plecanatide), manufactured by Synergy Pharmaceuticals. The drug is now indicated to treat adults who have irritable bowel syndrome with constipation (IBS-C).
An estimated 1 in 20 Americans have IBS-C, according to the International Foundation for Functional Gastrointestinal Disorders. In addition to constipation, IBS-C is often characterized by abdominal pain and cramping, bloating, and gas. Episodes of symptoms are typically frequent and can be highly disruptive to patient’s daily lives.
Originally approved in January of 2017 to treat chronic idiopathic constipation (CIC) in adults, Trulance is a guanylate cyclase-C agonist that is believed to work similarly to uroguanylin, a peptide naturally produced in the body that helps to ensure appropriate levels of fluid in the intestine for digestive health. Patients with IBS-C who received Trulance in clinical trials experienced improved bowel movements and significant reduction in abdominal pain compared to those given a placebo.
Recommended dosing is one 3mg tablet per day, with or without food. Trulance is not recommended for use in patients under 18 years of age, as studies indicate it may cause severe and potentially fatal dehydration in children and adolescents.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.