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LINZESS has met all primary endpoints in each of its five pivotal U.S. If severe diarrhea occurs, dosing should be suspended and the. Abdominal distention occurred more frequently in patients given 72 mcg (2) compared to patients given 145 mcg (1) doses. Severe diarrhea was reported in 2 of 145 mcg and 290 mcg LINZESS-treated patients, and in <1 of 72 mcg LINZESS-treated CIC patients. The most common adverse event was diarrhea the rates of diarrhea and of discontinuations due to diarrhea were numerically lower for the 72 mcg dose than the 145 mcg dose in this trial. The most commonly reported side effects included diarrhea, abdominal pain, flatulence, and headache.
#LINZESS 72 MCG TRIAL#
As previously reported, this trial met its primary endpoint the 72mcg dose demonstrated statistically significant improvement in Complete Spontaneous Bowel Movements compared to placebo over 12 weeks. The approval of LINZESS 72 mcg is based on results from a Phase III clinical trial of 1,223 adults with CIC. “LINZESS is the branded prescription market leader in the treatment of adult patients with IBS-C or CIC, and we believe the availability of a 72 mcg dose will enhance the product’s utility to physicians in treating patients across the broad CIC patient population, which encompasses up to 35 million adult Americans,” said Tom McCourt, Chief Commercial Officer at Ironwood.īill Meury, Chief Commercial Officer at Allergan, said, “This approval is testimony to the ongoing commitment of our organizations to continue to innovate with LINZESS and to enhance patient care and refine the treatment of gastrointestinal disorders such as CIC.” Since the launch of LINZESS in December of 2012, nearly 1.5 million unique patients have filled nearly 7 million prescriptions, according to IMS Health data. LINZESS is now FDA-approved in three dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), and 145 mcg and a new 72 mcg for the treatment of adults with CIC. The new dose is expected to be available in the first quarter of 2017. LINZESS is now FDA-approved in three dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), and 145 mcg and a new 72 mcg for the treatment of adults. The newly approved dose will provide physicians with dosing flexibility based on individual presentation or tolerability, in treating the large and heterogenous population of adult CIC patients. FDA has approved a 72 mcg dose of LINZESS ®(linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. Following oral administration of 72 mcg, 145 mcg, or 290 mcg of LINZESS once daily for 3 days to breastfeeding mothers taking linaclotide therapeutically, the concentrations of linaclotide and its metabolite were below the limits of quantitation (<0.25 ng/mL and <1 ng/mL, respectively) in all breast milk samples collected over 24 hours. Ironwood Pharmaceuticals, Inc. and Allergan plc announced that the U.S. Food and Drug Administration approves 72 mcg dose of LINZESS® (linaclotide) for adults with chronic idiopathic constipation.