AMITIZA is for Chronic Idiopathic Constipation (CIC) in adults, Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, and Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years. Effectiveness in patients taking diphenylheptane opioids has not been established.
Efficacy profile for OIC with chronic, non-cancer pain
The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established.
Definition of OIC across all 3 clinical studies
Patients who had been receiving stable opioid therapy for at least 30 days prior to screening, which was to continue throughout the 12-week treatment period.
These patients experienced < 3 SBMs per week, with at least 25% of SBMs associated with one or more of the following conditions:
- Hard to very hard stool consistency
- Moderate to very severe straining
- Having sensation of incomplete evacuation
A comparison of the proportion of overall responders* in clinical study 1
Study 1 was a randomized, double-blind, placebo-controlled, 12-week study in patients receiving non-diphenylheptane (e.g., non-methadone) opioid therapy for chronic, non-cancer-related pain.3
*Overall responders were defined as patients who experienced3
- ≥ 1 SBM improvement over baseline for all treatment weeks for which data was available, and
- ≥ 3 SBMs/week for at least 9 of 12 treatment weeks
Mean change from baseline in SBM frequency at Week 8 in studies 2 and 33
Studies 2 and 3 were randomized, double-blind, placebo-controlled, 12-week studies in patients receiving opioid therapy for chronic, non-cancer pain. Studies 2 and 3 did not exclude patients receiving diphenylheptane opioids (e.g., methadone).3
||Study 3 did not demonstrate statistically significant improvement in SBM frequency rates at Week 8.3