Submission details Identifying information Submission number PM-2016-02313-1-1 Sponsor Allergan Australia Trade name Viberzi Active substance Eluxadoline Submission type This was an application to register eluxadoline as a new chemical entity under the proposed trade name Viberzi. Drug class and therapeutic indication A locally acting mixed µ-opioid receptor (MOR) agonist/ receptor (DOR) antagonist δ-opioid with low oral bioavailability. Eluxadoline has been developed for the treatment in adults of irritable bowel syndrome with diarrhoea (IBS-d). The mixed opioid pharmacology of eluxadoline appears to confer on it the ability to effectively improve abdominal pain and stool consistency in IBS-d patients while mitigating the risk of constipation. The proposed Indication is: (eluxadoline) is indicated in adults for the treatment of irritable bowel syndrome ‘Viberzi with diarrhoea (IBS-d)’. Dosage forms and strengths The proposed film-coated tablets will contain eluxadoline 75 mg and 100 mg. Dosage and administration 100 mg strength The recommended dosage of Viberzi is 100 mg taken orally twice daily with food. 75 mg strength The recommended dosage of Viberzi is 75 mg taken orally twice daily with food in patients who: do not have a gallbladder; are unable to tolerate the 100 mg dose; have mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment; are receiving concomitant OATP1B1 inhibitors.
Submission details Identifying information Submission number PM-2016-02313-1-1 Sponsor Allergan Australia Trade name Viberzi Active substance Eluxadoline Submission type This was an application to register eluxadoline as a new chemical entity under the proposed trade name Viberzi. Drug class and therapeutic indication A locally acting mixed µ-opioid receptor (MOR) agonist/ δ-opioid receptor (DOR) antagonist with low oral bioavailability. Eluxadoline has been developed for the treatment in adults of irritable bowel syndrome with diarrhoea (IBS-d). The mixed opioid pharmacology of eluxadoline appears to confer on it the ability to effectively improve abdominal pain and stool consistency in IBS-d patients while mitigating the risk of constipation. The proposed Indication is: ‘Viberzi (eluxadoline) is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-d)’. Dosage forms and strengths The proposed film-coated tablets will contain eluxadoline 75 mg and 100 mg. Dosage and administration 100 mg strength The recommended dosage of Viberzi is 100 mg taken orally twice daily with food. 75 mg strength The recommended dosage of Viberzi is 75 mg taken orally twice daily with food in patients who: do not have a gallbladder; are unable to tolerate the 100 mg dose; have mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment; are receiving concomitant OATP1B1 inhibitors.