FDA Approves Supplemental New Drug Application for AMITIZA ® (lubiprostone), the First Oral Treatment for Opioid-induced Constipation in Adults with Chronic Non-Cancer Pain
AMITIZA Now Approved and Available for Three Separate Indications
BETHESDA, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP ) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Sucampo’s supplemental new drug application (sNDA) for AMITIZA® (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
This is the third indication for AMITIZA, which is also approved in the U.S. for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult women (8 mcg twice daily). There are more than 200 million prescriptions for opioid use in the U.S. annually, and a substantial number of these prescriptions are for non-cancer chronic pain.Scientific literature indicates that approximately 40-80% of patients taking opioids chronically for non-cancer pain report constipation.
“This approval from the FDA, which received priority review status, provides the first and only oral treatment option for opioid-induced constipation in adult patients with chronic, non-cancer pain. As a locally acting ClC-2 channel activator, AMITIZA enhances chloride secretion together with intestinal fluid, which is important in its role in treating OIC,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Scientific Officer, and Chief Executive Officer, Sucampo. “With this third indication for AMITIZA, we are pleased to be able to provide physicians an important new option to help treat the unmet needs of their patients.”
Opioid-based medicines are widely used in the management of chronic pain, with OIC being a common adverse effect of chronic opioid use. Some patients may discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.
“We are pleased with the FDA approval of this new indication for AMITIZA,” said Charlie Baum, Vice President, U.S. Medical Affairs, Takeda. “It is critical that we continue to identify and respond to the needs of physicians and their patients with OIC.”
AMITIZA is a specific activator of ClC-2 chloride channels in the intestinal epithelium. AMITIZA, via activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates.
This approval is based on results from Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids (among them morphine, oxycodone, and fentanyl) chronically for non-cancer pain, as well as a long-term, open-label safety study, which provides additional support for use in this population. Two of the Phase 3 studies met their overall efficacy endpoint, while a third Phase 3 study did not.
About Opioid Induced Constipation (OIC)
OIC is a common adverse effect of chronic opioid use. Binding of opioids to peripheral opioid receptors in the gastrointestinal tract results in absorption of electrolytes, such as chloride, and subsequent reduction in small intestinal fluid. In addition, activation of enteric opioid receptors results in abnormal GI motility. Together, these processes result in OIC, which is characterized by infrequent and incomplete evacuation of stool, hard stool consistency, and straining associated with bowel movements.
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).
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.
- Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their HCP.
- AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Patients should be instructed to discontinue AMITIZA and inform their HCP if severe diarrhea occurs.
- Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their HCP. 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) 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.
For further information, please visit www.sucampo.com/products for complete Prescribing Information.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman, Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com.
AMITIZA® is a registered trademark of Sucampo AG.
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Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.takeda.us.
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Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
Takeda Pharmaceuticals U.S.A., Inc.
Jessica Tuquero, 1-224-554-2021
Carrie Rose, 1-646-935-3938
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