User login
The Food and Drug Administration approved linaclotide on Aug. 30 to treat two conditions: chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
Linaclotide (Linzess) is administered as a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. This agent helps relieve constipation by increasing the frequency of bowel movements. In irritable bowel syndrome with constipation (IBS-C), linaclotide has been shown to reduce abdominal pain, according to a statement from the FDA.
The drug is approved with a boxed warning to alert patients and health care professionals that linaclotide should not be used in patients 16 years of age and younger. The most common side effect reported during the clinical studies was diarrhea, the statement said.
According to the FDA, the safety and effectiveness of linaclotide for the management of IBS-C were established in two double-blind studies (Gastroenterology 2011;140:S138 and Gastroenterology 2011;140:S135). A total of 1,604 patients were randomly assigned to take 290 mcg of linaclotide or a placebo for at least 12 weeks. Linaclotide was more effective in reducing abdominal pain and increasing the number of complete spontaneous bowel movements, compared with placebo, in both trials.
The safety and effectiveness of linaclotide for the management of chronic idiopathic constipation also were established in two double-blind studies (N. Engl. J. Med. 2011;365:527-36). A total of 1,272 patients were randomly assigned to take 145 mcg or 290 mcg linaclotide or a placebo for 12 weeks. Patients on linaclotide had more complete spontaneous bowel movements than did those taking the placebo. The 290-mcg dose is not approved for chronic constipation because the data showed that it was no more effective than the 145-mcg dose.
Linzess is marketed by Ironwood Pharmaceuticals Inc.
Linaclotide is currently the only FDA-approved medication indicated for increasing bowel movements and decreasing abdominal pain in men and women with irritable bowel syndrome with constipation (IBS-C). It has been shown to be efficacious in relieving abdominal pain and constipation in patients with IBS-C, and constipation in those with chronic idiopathic constipation (CIC). The drug is a peripherally-acting agent that activates guanylate cyclase-C (GC-C) on intestinal epithelial cells resulting in increased intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP).
Relief of constipation symptoms in IBS-C and CIC is believed to be due to an increase in intracellular cGMP resulting in chloride and fluid secretion through the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel and acceleration of colonic transit. Linaclotide’s effect on reducing abdominal pain in IBS-C is thought to be due to increased extracellular cGMP, which has been shown to decrease firing of sensory nerves within the bowel wall in preclinical animal studies.
Patients with CIC who responded to linaclotide had at least three complete spontaneous bowel movements (CSBMs) per week and an increase in one CSBM for at least 9 out of 12 weeks. The 145 mcg and 290 mcg daily doses showed a statistically significant benefit over placebo; the FDA has approved only the lower dose for CIC. The efficacy of linaclotide was sustained throughout the 12 weeks of the trials.
The dose of 290 mcg per day was approved for the treatment of IBS-C, which is usually differentiated from CIC by the presence of predominant abdominal pain associated with constipation. The significant improvement in CSBMs occurred within the first week of treatment. The decrease in abdominal pain was more gradual and appeared to reach its maximum effect at 8 weeks. The significant effect of linaclotide on abdominal pain may be due to an additional independent effect beyond relief of constipation, but further studies are needed to better understand linaclotide’s effect on abdominal pain.
LIN CHANG, M.D., is co-director of the Oppenheimer Family Center for Neurobiology of Stress and director of the Digestive Health and Nutrition Clinic at the University of California, Los Angeles. She is a consultant for Ironwood Pharmaceuticals and Forest Laboratories and has received grant support from Ironwood Pharmaceuticals.
Linaclotide is currently the only FDA-approved medication indicated for increasing bowel movements and decreasing abdominal pain in men and women with irritable bowel syndrome with constipation (IBS-C). It has been shown to be efficacious in relieving abdominal pain and constipation in patients with IBS-C, and constipation in those with chronic idiopathic constipation (CIC). The drug is a peripherally-acting agent that activates guanylate cyclase-C (GC-C) on intestinal epithelial cells resulting in increased intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP).
Relief of constipation symptoms in IBS-C and CIC is believed to be due to an increase in intracellular cGMP resulting in chloride and fluid secretion through the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel and acceleration of colonic transit. Linaclotide’s effect on reducing abdominal pain in IBS-C is thought to be due to increased extracellular cGMP, which has been shown to decrease firing of sensory nerves within the bowel wall in preclinical animal studies.
Patients with CIC who responded to linaclotide had at least three complete spontaneous bowel movements (CSBMs) per week and an increase in one CSBM for at least 9 out of 12 weeks. The 145 mcg and 290 mcg daily doses showed a statistically significant benefit over placebo; the FDA has approved only the lower dose for CIC. The efficacy of linaclotide was sustained throughout the 12 weeks of the trials.
The dose of 290 mcg per day was approved for the treatment of IBS-C, which is usually differentiated from CIC by the presence of predominant abdominal pain associated with constipation. The significant improvement in CSBMs occurred within the first week of treatment. The decrease in abdominal pain was more gradual and appeared to reach its maximum effect at 8 weeks. The significant effect of linaclotide on abdominal pain may be due to an additional independent effect beyond relief of constipation, but further studies are needed to better understand linaclotide’s effect on abdominal pain.
LIN CHANG, M.D., is co-director of the Oppenheimer Family Center for Neurobiology of Stress and director of the Digestive Health and Nutrition Clinic at the University of California, Los Angeles. She is a consultant for Ironwood Pharmaceuticals and Forest Laboratories and has received grant support from Ironwood Pharmaceuticals.
Linaclotide is currently the only FDA-approved medication indicated for increasing bowel movements and decreasing abdominal pain in men and women with irritable bowel syndrome with constipation (IBS-C). It has been shown to be efficacious in relieving abdominal pain and constipation in patients with IBS-C, and constipation in those with chronic idiopathic constipation (CIC). The drug is a peripherally-acting agent that activates guanylate cyclase-C (GC-C) on intestinal epithelial cells resulting in increased intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP).
Relief of constipation symptoms in IBS-C and CIC is believed to be due to an increase in intracellular cGMP resulting in chloride and fluid secretion through the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel and acceleration of colonic transit. Linaclotide’s effect on reducing abdominal pain in IBS-C is thought to be due to increased extracellular cGMP, which has been shown to decrease firing of sensory nerves within the bowel wall in preclinical animal studies.
Patients with CIC who responded to linaclotide had at least three complete spontaneous bowel movements (CSBMs) per week and an increase in one CSBM for at least 9 out of 12 weeks. The 145 mcg and 290 mcg daily doses showed a statistically significant benefit over placebo; the FDA has approved only the lower dose for CIC. The efficacy of linaclotide was sustained throughout the 12 weeks of the trials.
The dose of 290 mcg per day was approved for the treatment of IBS-C, which is usually differentiated from CIC by the presence of predominant abdominal pain associated with constipation. The significant improvement in CSBMs occurred within the first week of treatment. The decrease in abdominal pain was more gradual and appeared to reach its maximum effect at 8 weeks. The significant effect of linaclotide on abdominal pain may be due to an additional independent effect beyond relief of constipation, but further studies are needed to better understand linaclotide’s effect on abdominal pain.
LIN CHANG, M.D., is co-director of the Oppenheimer Family Center for Neurobiology of Stress and director of the Digestive Health and Nutrition Clinic at the University of California, Los Angeles. She is a consultant for Ironwood Pharmaceuticals and Forest Laboratories and has received grant support from Ironwood Pharmaceuticals.
The Food and Drug Administration approved linaclotide on Aug. 30 to treat two conditions: chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
Linaclotide (Linzess) is administered as a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. This agent helps relieve constipation by increasing the frequency of bowel movements. In irritable bowel syndrome with constipation (IBS-C), linaclotide has been shown to reduce abdominal pain, according to a statement from the FDA.
The drug is approved with a boxed warning to alert patients and health care professionals that linaclotide should not be used in patients 16 years of age and younger. The most common side effect reported during the clinical studies was diarrhea, the statement said.
According to the FDA, the safety and effectiveness of linaclotide for the management of IBS-C were established in two double-blind studies (Gastroenterology 2011;140:S138 and Gastroenterology 2011;140:S135). A total of 1,604 patients were randomly assigned to take 290 mcg of linaclotide or a placebo for at least 12 weeks. Linaclotide was more effective in reducing abdominal pain and increasing the number of complete spontaneous bowel movements, compared with placebo, in both trials.
The safety and effectiveness of linaclotide for the management of chronic idiopathic constipation also were established in two double-blind studies (N. Engl. J. Med. 2011;365:527-36). A total of 1,272 patients were randomly assigned to take 145 mcg or 290 mcg linaclotide or a placebo for 12 weeks. Patients on linaclotide had more complete spontaneous bowel movements than did those taking the placebo. The 290-mcg dose is not approved for chronic constipation because the data showed that it was no more effective than the 145-mcg dose.
Linzess is marketed by Ironwood Pharmaceuticals Inc.
The Food and Drug Administration approved linaclotide on Aug. 30 to treat two conditions: chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
Linaclotide (Linzess) is administered as a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. This agent helps relieve constipation by increasing the frequency of bowel movements. In irritable bowel syndrome with constipation (IBS-C), linaclotide has been shown to reduce abdominal pain, according to a statement from the FDA.
The drug is approved with a boxed warning to alert patients and health care professionals that linaclotide should not be used in patients 16 years of age and younger. The most common side effect reported during the clinical studies was diarrhea, the statement said.
According to the FDA, the safety and effectiveness of linaclotide for the management of IBS-C were established in two double-blind studies (Gastroenterology 2011;140:S138 and Gastroenterology 2011;140:S135). A total of 1,604 patients were randomly assigned to take 290 mcg of linaclotide or a placebo for at least 12 weeks. Linaclotide was more effective in reducing abdominal pain and increasing the number of complete spontaneous bowel movements, compared with placebo, in both trials.
The safety and effectiveness of linaclotide for the management of chronic idiopathic constipation also were established in two double-blind studies (N. Engl. J. Med. 2011;365:527-36). A total of 1,272 patients were randomly assigned to take 145 mcg or 290 mcg linaclotide or a placebo for 12 weeks. Patients on linaclotide had more complete spontaneous bowel movements than did those taking the placebo. The 290-mcg dose is not approved for chronic constipation because the data showed that it was no more effective than the 145-mcg dose.
Linzess is marketed by Ironwood Pharmaceuticals Inc.
