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, making it the first approved treatment for pediatric IBS-C.
The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.
Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.
IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval.
The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.
The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.
The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.
The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
, making it the first approved treatment for pediatric IBS-C.
The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.
Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.
IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval.
The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.
The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.
The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.
The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
, making it the first approved treatment for pediatric IBS-C.
The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.
Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.
IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval.
The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.
The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.
The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.
The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.