Therapy Areas: Central Nervous System
Shionogi Concludes a Contract for the Commercialization of Rizmoic, an Opioid-Induced Constipation Therapeutic Agent, in Germany, the UK, and the Netherlands
11 April 2019 - - Japanese pharmaceutical company Shionogi and Co., Ltd. has concluded a distribution contract with Germany-based Sandoz for the sale of Rizmoic (naldemedine) for the treatment of opioid-induced constipation in adult patients previously treated with a laxative in the key European markets of Germany, the UK, and the Netherlands, plus right of first refusal for certain other European markets, the company said.

Sandoz has a strong presence in the European market for opioid analgesics, as well as a complementary strategic focus on innovative therapeutic alternatives to combat opioid dependency.

According to this contract, Sandoz will commercialize Rizmoic in Germany, the UK, and the Netherlands, and Shionogi will be responsible for its manufacturing and development.

On February 22, 2019, the European Commission granted the Marketing Authorization for Rizmoic for the treatment of OIC in adult patients who have previously been treated with a laxative.

Rizmoic is planned to be launched in Germany and the UK in 2019 and in the Netherlands in 2020. Rizmoic was launched under the brand name Symproic in Japan in June 2017, and in the United States in October 2017.

Shionogi plans to initiate a clinical study of naldemedine in paediatric patients with OIC in EU, in accordance with an agreed paediatric investigation plan, as well as a clinical study in adult patients with post-operative ileus.

Shionogi's research and development efforts target pain/central nervous system as one of its priority areas in the mid-term business plan, SGS2020, in which Shionogi has positioned "Grow sustainably as a drug discovery-based pharmaceutical company contributing to a more vigorous society through improved healthcare" as its vision.

Shionogi constantly strives to improve the quality of life of patients who suffer from pain or side effects of analgesics by bringing forth innovative drugs.

Constipation is one of the most commonly reported side effects associated with opioid treatment, particularly among patients with chronic non-cancer pain and patients with cancer pain.

OIC is a result of increased fluid absorption and reduced gastro-intestinal motility due to mu-opioid receptor binding in the GI tract.

OIC is defined as a change in bowel habits that is characterized by any of the following after initiating opioid therapy: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency.

In patients receiving opioid therapy for chronic non-cancer pain, the prevalence of OIC ranges from approximately 40-60%.

Rizmoic (naldemedine) is indicated for the treatment of opioid-induced constipation in adult patients who have previously been treated with a laxative. Rizmoic is a peripherally acting mu-opioid receptor antagonist (PAMORA) that has been developed by Shionogi as a once-daily treatment of OIC.

The efficacy and safety of naldemedine have been evaluated in randomized, double-blinded, placebo-controlled studies in adult patients with OIC who have chronic non-cancer pain or who have cancer pain.

Rizmoic is expected to be a new treatment option that can improve the quality of life significantly in patients with OIC in pain management with opioid analgesics.

Shionogi and Co., Ltd. is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and wellbeing of the patients we serve."

The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and gastroenterology.

Shionogi's research and development currently target two therapeutic areas: infectious diseases and pain/CNS disorders.