Linaclotide is supposed to be their next billion dollar plus blockbuster drug for irritable bowel syndrome. The review period was extended by 3 months a while ago to September. Can it be approved before then? That would be an interesting squeeze.
PDUFA: September 8Peak Sales Estimate: $500MSpecific AE Profile (based on P-IIIa):Linaclotide N=402Placebo N=403DiarrheaL 20%P 2%–MildL 8%P 2%–ModerateL 10%P 0.2%–SevereL 2%P 0%-Discontinued due to any AEL 10%P 2%Discontinued due to diarrheaL 4%P 0.2%Note: P IIIb is ongoing.
Ongoing P-IIIb Studyhttp://clinicaltrials.gov/ct2/show/NCT01642914?term=linaclotide&rank=1Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Predominant Abdominal BloatingThe study started: August 2012 (followed last PDUFA, June 2012)Size: 450Final data collection date for primary outcome measure: September 2013QUESTION: what will FDA say on coming PDUFA, September 2012?