“MOVICOL® HD” Launched- A New Dosage Form Added to Polyethylene Glycol Chronic Constipation
Treatment for the First Time in Japan This material is an English translation of the press release to be issued on May 20, 2022 inJapanese, and the Japanese release is given priority regarding content and interpretation.
May 20, 2022
Mochida Pharmaceutical Co., Ltd.
EA Pharma Co., Ltd.
Eisai Co., Ltd.
Mochida Pharmaceutical Co., Ltd. (President, Naoyuki Mochida; Headquarters, Shinjuku-ku,Tokyo, Japan, “Mochida”), EA Pharma Co., Ltd. (President, Hidenori Yabune; Headquarters,Chuo-ku, Tokyo, Japan, “EA Pharma”) and EA Pharma’s parent company Eisai Co., Ltd. (CEO,Haruo Naito; Headquarters, Bunkyo-ku, Tokyo, Japan, "Eisai") announced today that
“MOVICOL® HD”, a chronic constipation treatment, was launched by Mochida and EA Pharma.
MOVICOL® HD is a high dose formulation of existing “MOVICOL® LD”, the first polyethylene
glycol indicated for treatment of chronic constipation1) in Japan. MOVICOL® HD contains thesame active ingredients in double the quantity of MOVICOL® LD per sachet. For the patients
who have previously used 2 sachets of MOVICOL® LD per dose, MOVICOL® HD can save thetime and effort of opening multiple sachets, increasing convenience, reducing the economic
burden and reducing packing waste.
MOVICOL® LD and MOVICOL® HD (collectively “MOVICOL®”) are indicated for children of 2
years and above and adults patients2). MOVICOL® is a powdered medicine to be dissolved inwater before administration, which enables suitable increase or decrease of the dose to obtain
the preferred stool consistency. MOVICOL® increases the water retention in the intestinal tractby osmolality of its main ingredient polyethylene glycol (macrogol 4000), which increases fecal
moisture, softens feces, increases fecal volume and physiologically activates the peristaltic
movement of the colon to promote bowel movement.

1Outside Japan, MOVICOL® has been marketed in mainly in Europe by Norgine B.V.
(Headquarters, the Netherlands, “Norgine”) under the brand name MOVICOL* and is used bymany patients with chronic constipation. In Japan, the Evaluation Committee on Unapprovedor Off-Labeled Drugs with High Medical Needs3) of Ministry of Health, Labour and Welfare
recognized the “high unmet medical needs” of polyethylene glycol preparations for chronic
constipation, and Ajinomoto Pharmaceuticals Co., Ltd. (now EA Pharma) developed
MOVICOL® with Mochida for oral chronic constipation treatment in pediatric and adult patientsin Japan under the license granted by Norgine to Ajinomoto Pharmaceuticals Co., Ltd. (nowEA Pharma).
Mochida and EA Pharma start today distribution of MOVICOL® HD under the same brandname in Japan. EA Pharma and Eisai jointly provide information for the proper use ofMOVICOL® HD under a co-promotion agreement.
The prevalence of constipation is high in young women and both elderly men and women, andthe symptoms can become severe particularly in pediatric patientsa)b). The symptoms ofconstipation include reduced bowel movement, feeling of incomplete evacuation, and hardstools. When the symptoms become chronic, many patients suffer from a decline of QOL(Quality of Life)c). With the new dosage form MOVICOL® HD in addition to “GOOFICE® 5 mg
Tablet” (bile acid transporter inhibitor for chronic constipation1) treatment) and MOVICOL® LD(polyethylene glycol), Mochida, EA Pharma and Eisai are striving to increase treatment optionsfor patients with chronic constipation and diverse disease histories as they seek to further
contribute to addressing the needs of, and increasing the benefits provided to, patients, theirfamilies and healthcare providers.
1)

Excluding structural disease-induced constipation

2)

Please see the package insert for proper use guidance.

3)

The Evaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Needs
This committee was organized in the Ministry of Health, Labour and Welfare to evaluate the medical needs of the drugsand indications that are not approved in Japan (“unapproved or off-labeled drugs”) and the appropriateness of filing thepublic knowledge-based application and requirement of additional studies for filing the marketing and manufacturing
application to promote development of unapproved or off-labeled drugs by pharmaceutical companies.

【References】a)Rates of people who have subjective symptoms of constipation by age and gender, Comprehensive Survey of Living
Conditions 2016, Ministry of Health, Labour and Welfareb)

Guideline for Diagnosis of Chronic Functional Constipation in Pediatrics edited by Japanese Society for Pediatric
Gastroenterology, Hepatology and Nutrition and Japanese Society for Pediatric Neurogastroenterology; p.23-24,
SHINDAN TO CHIRYO SHA, Inc. 2013c)

Tomita T, Miwa H. JGH 2020 Oct 13. doi: 10.1111/jgh.15295.

Media Inquiries
Mochida Pharmaceutical

EA Pharma Co., Ltd.

Eisai Co., Ltd.

Co., Ltd.

Corporate Communication Dept.

PR Dept.

Public Relations

TEL： +81(0)80-4176-5206

TEL： +81(0)3-3817-5120

TEL： +81(0)3-3225-6303
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More Information
1. “MOVICOL® LD, MOVICOL®HD” Product Outline
Brand name
MOVICOL® LD, MOVICOL® HD
macrogol 4000, sodium chloride, sodium bicarbonate, potassium
Ingredientschloride
Powdered preparation for oral fluid
MOVICOL®
Active ingredientsLDHD

1 sachet（6.8523g） 1 sachet（13.7046g）
Formulation
ContentsIndication

Macrogol 4000

6.5625 g

13.1250 g

Sodium chloride

0.1754 g

0.3508 g

Sodium bicarbonate

0.0893 g

0.1786 g

Potassium chloride

0.0251 g

0.0502 g

Chronic constipation (excluding structural disease-inducedconstipation)
Dissolve this powdered medicine in water and administer orally.
For children aged 2-6 years, normally 1 sachet of MOVICOL® LD(“LD”) should be administered orally at once per day for the initialdose. Then, the dose can be increased or decreased depending onsymptoms, administered orally 1-3 times per day. The maximum
daily dose is 4 sachets of LD or 2 sachets of MOVICOL® HD (“HD”),(up to 2 LD sachets or 1 HD sachet at once). An interval of at least
2 days is needed between every dose escalation, and the doseshould not be increased in excess of 1 LD sachet per day.

Dosageand administration

For children aged 7-11 years, normally 2 LD sachets or 1 HD sachet
should be administered orally at once per day for the initial dose.
Then, the dose can be increased or decreased depending on
symptoms, administered orally 1-3 times per day. The maximum
daily dose is 4 LD sachets or 2 HD sachets (up to 2 LD sachets or 1
HD sachet at once). An interval of at least 2 days is needed between
every dose escalation, and the dose should not be increased inexcess of 1 LD sachet per day.
For adults and children aged 12 years and older, normally 2 LD
sachets or 1 HD sachet should be administered orally at once perday for the initial dose. Then, the dose can be increased ordecreased depending on symptoms, administered orally 1-3 times
per day. The maximum daily dose is 6 LD sachets or 3 HD sachets(up to 4 LD sachets or 2 HD sachets at once). An interval of at least
2 days is needed between every dose escalation, and the doseshould not be increased in excess of 2 LD sachets or 1 HD sachet
per day.
3(continued on following page)Age
2-6 years

Dose
Initial dose
Maximum dose

1 sachet－Per dose2 sachets

1 sachet

dose per day Per day

4 sachets

2 sachets

2 sachets

1 sachet

1 sachet－Per dose2 sachets

1 sachet

dose per day Per day

4 sachets

2 sachets

Initial dose2 sachets

1 sachet

2 sachets

1 sachet

Per dose

4 sachets

2 sachets

dose per day Per day

6 sachets

3 sachets

escalation* per day
Maximum
7-11 years Initial dose
Maximum dose
Dosageand administration

escalation* per day
Maximum
12 years

and above, Maximum dose
AdultsMOVICOL®
LDHD
1 sachet－escalation* per day
Maximum*An interval of at least 2 days is needed between every dose
escalation.
Packaging
National Health
Insurance Drug(NHI) Price
Date of manufactureand marketing
approval
Date of inclusion in
the NHI drug pricelist
Launch100 sachets
MOVICOL® LD
MOVICOL® HD

1 sachet ¥75.30
1 sachet ¥131.60

MOVICOL® LD September 21, 2018
MOVICOL® HD January 25, 2021
MOVICOL® LD November 20, 2018
MOVICOL® HD November 25, 2021
MOVICOL® LD November 29, 2018
MOVICOL® HD May 20, 2022

Manufacturer and
EA Pharma Co., Ltd.
distributor
Promotion alliancewith EA Pharma Co., Eisai Co., Ltd.
Ltd.
Distributor
Mochida Pharmaceutical Co., Ltd.

4

2. About “GOOFICE® 5 mg Tablet”“GOOFICE® 5 mg Tablet”, which EA Pharma in-licensed from Albireo AB (Headquarters,Sweden), is an orally available chronic constipation* treatment having a novel mechanism ofaction. “GOOFICE® 5 mg Tablet” inhibits the bile acid transporter that regulates reabsorptionof bile acids thereby increasing the flow of bile acids to the colon, which is expected to enhancecolonic motility. Mochida and EA Pharma have a joint development and marketing agreementfor “GOOFICE® 5 mg Tablet”, and started distribution of “GOOFICE® 5 mg Tablet” respectively
under the same brand name on April 19, 2018 in Japan. EA Pharma also has a co-promotion
agreement with Eisai. EA Pharma and Eisai jointly provide information for the proper use of“GOOFICE® 5 mg Tablet”.
*Excluding structural disease-induced constipation

3. About Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has been committed to research and development ofinnovative pharmaceutical products since its establishment thereby providing distinctive
medicines to the medical field. Currently, the core pharmaceutical business focuses resourceson the targeted areas of cardiovascular medicine, obstetrics and gynecology, psychiatry andgastroenterology, while also providing medicine for intractable disease as well as generics
including biosimilars, to meet medical needs.
For more information on Mochida Pharmaceutical Co., Ltd., please see
https://www.mochida.co.jp/english/

4. About EA Pharma Co., Ltd.
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, wasestablished in April 2016 by integration of the gastrointestinal business unit with more than 60
year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group
having amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma with afull value chain covering R&D, logistics and sales & marketing.
For more information on EA Pharma Co., Ltd., please see https://www.eapharma.co.jp/en/

5. About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company
headquartered in Japan. We define our corporate mission as "giving first thought to patientsand their families and to increasing the benefits health care provides," which we call our humanhealth care (hhc) philosophy. With approximately 10,000 employees working across our global
network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize
our hhc philosophy by delivering innovative products to address unmet medical needs, with aparticular focus in our strategic areas of Oncology and Neurology.
For more information on Eisai Co., Ltd., please see https://www.eisai.com/*“MOVICOL” is a registered trademark of the Norgine group.
(In this document, MOVICOL means the product marketed in non-Japan countries.)5