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CLINICAL TRIALS PROFILE FOR MOVANTIK

All Clinical Trials for Movantik

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02705378 ↗	The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit	Withdrawn	AstraZeneca	Phase 3	2017-05-01	Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.
NCT02705378 ↗	The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit	Withdrawn	Massachusetts General Hospital	Phase 3	2017-05-01	Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.
NCT02737059 ↗	Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects	Completed	AstraZeneca	Phase 1	2016-07-01	This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine. The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.
NCT02737059 ↗	Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects	Completed	Michael Camilleri	Phase 1	2016-07-01	This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine. The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.
NCT02745353 ↗	Naloxegol in Cancer Opioid-Induced Constipation	Terminated	AstraZeneca	Phase 2	2016-05-01	The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.
NCT02745353 ↗	Naloxegol in Cancer Opioid-Induced Constipation	Terminated	Joseph Ma	Phase 2	2016-05-01	The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.
NCT02745353 ↗	Naloxegol in Cancer Opioid-Induced Constipation	Terminated	University of California, San Diego	Phase 2	2016-05-01	The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.

Clinical Trial Conditions for Movantik

Condition Name

Condition Name for Movantik
Intervention	Trials
Constipation	6
Constipation Drug Induced	3
Healthy	1
Opioid Induced Constipation	1

Condition MeSH

Condition MeSH for Movantik
Intervention	Trials
Constipation	10
Opioid-Induced Constipation	6
Critical Illness	2
Prolapse	1

Clinical Trial Locations for Movantik

Trials by Country

Trials by Country for Movantik
Location	Trials
United States	37
Belgium	1

Trials by US State

Trials by US State for Movantik
Location	Trials
Ohio	4
Massachusetts	4
Pennsylvania	3
Missouri	2
North Carolina	2

Clinical Trial Progress for Movantik

Clinical Trial Phase

Clinical Trial Phase for Movantik
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Movantik
Clinical Trial Phase	Trials
Terminated	5
Completed	3
Withdrawn	3

Clinical Trial Sponsors for Movantik

Sponsor Name

Sponsor Name for Movantik
Sponsor	Trials
AstraZeneca	8
Temple University	2
Massachusetts General Hospital	2

Sponsor Type

Sponsor Type for Movantik
Sponsor	Trials
Other	18
Industry	8

Movantik: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Movantik (naloxegol) is a peripherally acting mu-opioid receptor antagonist (PAMORA) specifically designed to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Developed by Nektar Therapeutics and initially licensed by AstraZeneca, Movantik has undergone extensive clinical trials and has seen significant market developments.

Clinical Trials Overview

Phase III Clinical Studies: KODIAC Program

The approval of Movantik was based on the results of the KODIAC clinical program, which included four key studies: KODIAC-4, KODIAC-5, KODIAC-7, and KODIAC-8. These studies were pivotal in establishing the safety and efficacy of Movantik.

• KODIAC-4 and KODIAC-5: These were 12-week, placebo-controlled, double-blind studies that evaluated the response rates of patients receiving either 12.5mg or 25mg of Movantik. In KODIAC-4, 44% of patients on the 25mg dose and 41% on the 12.5mg dose responded, compared to 29% on placebo. Similar results were observed in KODIAC-5, with response rates of 40% for the 25mg dose and 35% for the 12.5mg dose, versus 29% for placebo[1][4].

• KODIAC-7: This was a 12-week extension study to KODIAC-4, focusing on safety evaluation. The study found lower rates of adverse events and serious adverse events compared to the initial studies[1].

• KODIAC-8: A 52-week study, KODIAC-8 evaluated the long-term safety of Movantik. The results were consistent with earlier phase III studies, showing no increase in serious adverse events[1].

Adverse Events and Safety Profile

The most common adverse events observed during these clinical trials included abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache. Despite these side effects, the overall safety profile of Movantik was found to be favorable, with no significant elevation in serious adverse events[1][4].

Market Analysis

Commercialization and Licensing

Movantik was initially commercialized by AstraZeneca in collaboration with Daiichi Sankyo in the US and ProStrakan Group (now KKI) in the EU. However, in February 2020, AstraZeneca divested its global rights to Movantik (excluding Europe, Canada, and Israel) to RedHill Biopharma. This move supported AstraZeneca's strategy to focus on its core therapy areas and ensured the continued availability of Movantik for patients[2].

Market Coverage and Access

RedHill Biopharma's acquisition of the global marketing rights has significantly expanded the market coverage of Movantik. As of July 2021, Movantik was listed as a preferred brand on a national formulary serving some Blue Cross plans, extending its commercial coverage to 152 million American patients. This development has strengthened Movantik's market position and increased patient access to the drug[5].

Financial Considerations

The divestment of Movantik to RedHill Biopharma included an upfront payment of $52.5 million and a further non-contingent payment of $15 million in 2021. In 2019, Movantik generated $96 million in sales in the US, indicating a substantial market presence[2].

Projections and Future Outlook

Continued Market Growth

Given its preferred brand status on several formularies and the expanding coverage, Movantik is expected to continue its market growth. The drug's efficacy, particularly in older adults and across various opioid doses, as demonstrated in recent analyses presented at PAINWeek 2021, further supports its market potential[4].

Addressing Opioid-Induced Constipation

As opioid therapy remains a common treatment for chronic pain, the prevalence of OIC is likely to persist. Movantik's role in managing this condition is crucial, and its continued availability ensures that patients have an effective treatment option. The clinical shift towards lower dose opioid therapy, which still poses a risk of OIC, underscores the ongoing need for Movantik[4].

Regulatory and Competitive Landscape

Movantik's approval in the US and EU, along with its recent market expansions, positions it favorably in the competitive landscape of OIC treatments. However, ongoing regulatory scrutiny and the emergence of new treatments could influence its market share. RedHill Biopharma's commitment to maintaining and expanding Movantik's market presence will be key to its future success[2][5].

Key Takeaways

• Clinical Efficacy: Movantik has demonstrated significant efficacy in treating OIC through the KODIAC clinical program.
• Market Expansion: The drug has seen substantial market growth, with expanded coverage to 152 million American patients.
• Safety Profile: Movantik has a favorable safety profile, with common adverse events manageable and no significant increase in serious adverse events.
• Financial Performance: The drug generated $96 million in US sales in 2019 and is expected to continue contributing to RedHill Biopharma's revenue.
• Future Outlook: Movantik is projected to maintain its market position due to its efficacy, expanded coverage, and ongoing need for OIC management.

FAQs

What is Movantik used for?

Movantik (naloxegol) is used for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Who developed Movantik?

Movantik was developed by Nektar Therapeutics using proprietary oral small molecule polymer conjugate technology.

What are the common adverse events associated with Movantik?

Common adverse events include abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache.

Who currently holds the global rights to Movantik?

RedHill Biopharma holds the global rights to Movantik, excluding Europe, Canada, and Israel, which were acquired from AstraZeneca in 2020.

How has Movantik's market coverage expanded?

Movantik was listed as a preferred brand on a national formulary serving some Blue Cross plans, extending its commercial coverage to 152 million American patients.

What are the key findings from the KODIAC clinical studies?

The KODIAC studies demonstrated that Movantik significantly improved response rates in patients with OIC, with no elevation in serious adverse events over long-term use.

Sources

1. Clinical Trials Arena: "Movantik for the Treatment of Opioid-Induced Constipation"
2. AstraZeneca: "AstraZeneca divests global rights to Movantik"
3. FDA: "204760Orig1s000 - accessdata.fda.gov"
4. PR Newswire: "RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021"
5. Managed Healthcare Executive: "Movantik Chosen as Preferred Brand for Some Blue Cross Plans"