Clinical data for IBS-C

Indication

AMITIZA (lubiprostone) capsules are indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

AMITIZA clinical data for IBS-C

Clinical studies found that AMITIZA provides improvement of global Irritable Bowel Syndrome with Constipation (IBS-C) symptoms.1 Global IBS symptoms were defined as abdominal discomfort/pain, bowel habits, and other IBS symptoms.

Efficacy study results for IBS-C

STUDY DESIGN

Two multicenter, double-blind, randomized, placebo-controlled, 12-week studies of patients with IBS-C were conducted.1,7

Summary of overall responder rates1,7

Summary of overall responder rates
Patient population: intent-to-treat

AMITIZA had up to 2x Overall Responder rate vs placebo.1

In 2 clinical studies, the primary endpoint was overall Responders to the question:1

  • "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits, and other IBS symptoms) over the past week compared to how you felt before you entered the study?"
  • Overall Responder was defined as Monthly Responder for at least 2 months in the 3-month study
  • Monthly Responder was defined as a patient who reported “significantly relieved” for at least 2 weeks of the month or at least "moderately relieved" in all 4 weeks of that month
  • During each monthly evaluation period, patients reporting “moderately worse” or “significantly worse” relief, an increase in rescue medication use, or those who discontinued due to lack of efficacy, were deemed non-responders

IBS was defined as1

  • Abdominal pain or discomfort occurring over at least 6 months with 2 or more of the following: relieved with defecation, onset associated with a change in stool frequency, onset associated with a change in stool form

Patients were subtyped as having IBS-C if they also experienced 2 of 3 of the following1

  • < 3 SBMs per week
  • > 25% hard stools
  • > 25% SBMs associated with straining

Results in men

The 2 randomized, placebo-controlled, double-blinded studies comprised 97 (8.4%) male patients, which is insufficient to determine whether men with IBS-C respond differently to AMITIZA than women.1

AMITIZA withdrawal study for IBS-C1

During a 4-week randomized withdrawal period following Study 1, patients with IBS-C who received AMITIZA during the 12-week treatment period were re-randomized to receive either placebo or to continue treatment with AMITIZA.1

  • Spontaneous bowel movement (SBM) frequency rates did not result in worsening compared to baseline for AMITIZA-treated patients who were “overall responders” during Study 1 and who were re-randomized to placebo

Important Safety Information

AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.

Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.

Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.

Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Indications

AMITIZA (lubiprostone) capsules are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

Please click here for complete Prescribing Information.
  1. AMITIZA (lubiprostone) Prescribing Information. Sucampo Pharma Americas, LLC.
  2. Hall JE. Textbook of Medical Physiology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:773-788.
  3. Keely SJ, Montrose MH, Barrett KE. In: Yamada T, Alpers DH, Kalloo AN, Kaplowitz N, Owyang C, Powell DW, eds. Textbook of Gastroenterology. 5th ed. West Sussex, England: John Wiley & Sons Ltd; 2009:330-367.
  4. Data on file. Takeda Pharmaceuticals.
  5. Johanson JF, Morton D, Geenen J, Ueno R. Am J Gastroenterol. 2008;103:170-177.
  6. Barish CF, Drossman D, Johanson JF, Ueno R. Dig Dis Sci. 2010;55:1090-1097.
  7. Data on file. Sucampo Pharma Americas, LLC.

Important Safety Information

AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.

Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.

Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.

Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Indications

AMITIZA (lubiprostone) capsules are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

Please click here for complete Prescribing Information.
  1. AMITIZA (lubiprostone) Prescribing Information. Sucampo Pharma Americas, LLC.
  2. Hall JE. Textbook of Medical Physiology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:773-788.
  3. Keely SJ, Montrose MH, Barrett KE. In: Yamada T, Alpers DH, Kalloo AN, Kaplowitz N, Owyang C, Powell DW, eds. Textbook of Gastroenterology. 5th ed. West Sussex, England: John Wiley & Sons Ltd; 2009:330-367.
  4. Data on file. Takeda Pharmaceuticals.
  5. Johanson JF, Morton D, Geenen J, Ueno R. Am J Gastroenterol. 2008;103:170-177.
  6. Barish CF, Drossman D, Johanson JF, Ueno R. Dig Dis Sci. 2010;55:1090-1097.
  7. Data on file. Sucampo Pharma Americas, LLC.