Ironwood Announces Publication in The Lancet Gastroenterology & Hepatology of New Linaclotide Phase III Data in Children and Adolescents Aged 6-17 Years with Functional Constipation - Seite 2

Overall, linaclotide was well-tolerated in this study. Both study arms had similar proportions of patients with AEs: TEAEs (LIN, 17%; PBO, 21%), serious AEs (1.2% for both), and TEAEs leading to study treatment discontinuation (LIN, 1.2%, PBO, 1.8%). The most reported treatment-emergent adverse event (TEAE) by patients treated with linaclotide was diarrhea (seven [4%] of 164) and by patients treated with placebo was COVID-19 (five [3%] of 164). The most frequent treatment-related TEAE was diarrhea (linaclotide: six [4%] patients; placebo: two [1%] patients). The safety profile of linaclotide in pediatric patients is consistent with prior linaclotide studies in adults.

The manuscript published in The Lancet Gastroenterology & Hepatology further described that:

• A greater percentage of patients in the linaclotide treatment group were weekly SBM responders (patients who had an increase ≥2 in the SBM weekly rate from baseline for that week) compared with the placebo group at weeks 1, 3, 4, 6, 7, 11, and 12 (p < 0·05).
• Of the patients receiving rescue medicines, significantly fewer patients reported an increase in rescue medication use or use of any other laxative, suppository, or enema in the linaclotide group (25 of 164; 15·2%) compared with the placebo group (43 of 164; 26·2%) [p=0·015].

Linaclotide (marketed as LINZESS) 72mcg is available in the U.S. for the treatment of functional constipation for pediatric patients aged 6-17 years old.

“We are committed to providing ongoing data about our products to medical professionals and the scientific community,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president, and head of research and drug development at Ironwood Pharmaceuticals. “The publication of these results in The Lancet Gastroenterology & Hepatology adds to the body of knowledge about linaclotide and helps close the unmet needs gap in pediatric patients ages 6- 17 with FC.”

About Linaclotide

LINZESS is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data.

LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. LINZESS relieves constipation in children and adolescents aged 6 to 17 years with functional constipation. The recommended dose in adults is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC depending on individual patient presentation or tolerability. In children with functional constipation aged 6 to 17 years, the recommended dose is 72 mcg.