Cipher Pharmaceuticals Receives Health Canada Approval For Trulance® (Plecanatide)
OAKVILLE, ON, Oct. 18, 2019 /CNW/ – Cipher Pharmaceuticals Inc. (TSX: CPH) (“Cipher” or “the Company”) today announced it has received Health Canada approval, on October 10, 2019, for TRULANCE® (plecanatide), a Guanylate cyclase-C (GCC) agonist in the form of a once-daily tablet for the treatment of adults with irritable bowel syndrome with constipation (“IBS-C”).
“We are pleased to announce TRULANCE® has achieved Health Canada approval and we are excited to be able to bring this new and effective treatment option to Canadians who suffer from this condition,” said Craig Mull, Interim CEO of Cipher.
It is estimated that one in four Canadians has symptoms of constipation and an estimated 38% of Canadians report constipation within the previous 12 months1. According to IQVIA the total Canadian laxative and antispasmodic market (prescription and OTC) was valued at over CDN $200 million for the 12 months ending December 2018.
Consistent with its strategy to focus on partnering assets, Cipher is in the process of selecting a distribution partner for TRULANCE® that possesses the expertise and scale to successfully bring this novel product to market.
Cipher acquired the Canadian rights to develop, market, distribute and sell TRULANCE® from Bausch Health Companies Inc.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with either a change in the frequency of stool, or a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25% of the time.
TRULANCE® is a once-daily tablet approved by Health Canada for adults with IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE® is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. For more information, visit www.cipherpharma.com.
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(1) “Understanding the Prevalence and Impact of Constipation in Canada“: A Special Report from the Canadian Digestive Health Foundation.
SOURCE Cipher Pharmaceuticals Inc.