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Motegrity(TM) (prucalopride), the Only Serotonin-4 Receptor Agonist for Adults with Chronic Idiopathic Constipation (CIC), is Now Available in the United States
LEXINGTON, Mass., April 2, 2019 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc., ("Takeda") today announced that Motegrity™ (prucalopride), a once-daily, oral treatment option, is now commercially available by prescription in the United States for adults with chronic idiopathic constipation (CIC).1
Motegrity, a selective serotonin-4 (5-HT4) receptor agonist, works differently from other available treatments by enhancing colonic peristalsis to increase bowel motility.1-3 While not all patients may be right for treatment, Motegrity is an important new treatment option that is now available for this patient population.
"There is a significant unmet patient need for adults living with chronic idiopathic constipation (CIC) in the United States," said Tom Koutsavlis, Head, U.S. Medical Office, Takeda. "Takeda is committed to bringing innovative solutions to patients and GI is one of our key therapeutic areas. We are proud to offer Motegrity, the only, once-daily, selective 5-HT4 receptor agonist drug, as a new treatment option for patients who are suffering from this common GI condition."
CIC affects about 14% of the adult population.4,5* Symptoms can range from straining and bloating, to infrequent, or incomplete bowel movements. While "idiopathic" by definition (meaning the exact cause is not known), it is believed that CIC may be caused by insufficient movement of the colon muscle.6
About Motegrity™ (prucalopride) tablets
Name of the product
Motegrity™ is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation in adults.
· Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
· Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum.
Dosage and administration
Tablets: 1 mg, 2 mg of prucalopride
Take with or without food.
Recommended dosage by patient population:
· Adults: recommended oral dose regimen is 2 mg once daily.
· Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min): recommended oral dose regimen is 1 mg once daily.
Warnings and Precautions
Suicidal Ideation and Behavior: In clinical trials, suicides, suicide attempts and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Monitor patients for persistent worsening of depression and emergence of suicidal thoughts and behavior. Instruct patients to discontinue Motegrity immediately and contact their healthcare provider if their depression is persistently worse, or they experience emerging suicidal thoughts or behaviors.
Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
Use in Specific Populations
· Lactation: Motegrity is present in breast milk. Consider risks and benefits of breastfeeding.
· Pediatric: Safety and effectiveness in pediatric patients have not been established.
· Renal Impairment: A decreased dosage is recommended in patients with severe renal impairment. Avoid Motegrity in patients with end-stage renal disease requiring dialysis.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Takeda's Commitment to Gastroenterology
Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.
About Takeda in the United States
Takeda has maintained a strong and growing commitment to the United States for more than 50 years. On January 8, 2019, Takeda completed its acquisition of Shire, PLC, becoming a global, values-based, R&D-driven biopharmaceutical leader. In the U.S., Takeda employs more than 18,000 employees across multiple business units, and as of August 2019, will be headquartered out of the greater Boston area.
Additionally, Takeda also has a research facility in San Diego, California, specialty products manufacturing facilities in Brooklyn Park, Minnesota and plasma fractionation manufacturing facilities in Covington, Georgia.
As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.
* This represents ~14% of the U.S. population as of July 1, 2017 Census Bureau Data
1. Motegrity™ (prucalopride) Prescribing Information. Lexington, MA; Shire LLC; 2018.
2. Camilleri M, Ford AC, Mawe GM, et al. Nat Rev Dis Primers.2017;3:17095.
3. Tack J, Camilleri M, Chang L, et al. Aliment Pharmacol Ther. 2012:35(7):745-767.
4. U.S. Census Bureau. Quick Facts (2017). https://www.census.gov/quickfacts/fact/table/US/PST045216.
5. Suares NC, Ford AC. Am J Gastroenterol. 2011;106(9):1582-1591.
6. Lacy BE, Mearin F, Chang L, et al. Gastroenterology 2016;150:1393–1407.
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SOURCE Takeda Pharmaceuticals U.S.A., Inc.