May 29, 2012
Launch and Co-Promotion of "MINIRINMELT® OD Tablet 120μg / 240μg",
A Treatment of Nocturnal Enuresis / Bedwetting
Tokyo, Japan, May 29, 2012 --- Ferring Pharmaceuticals Co., Ltd. ("Ferring") announced the launch of "MINIRINMELT® OD Tablet 120μg / 240μg" (generic name: desmopressin acetate hydrate) ("MINIRINMELT® OD Tablet") for the treatment of nocturnal enuresis / bedwetting associated with decrease in urine osmolarity or urine specific gravity on May 29 following the NDA approval on March 30 and the NHI drug price listing received on May 29. Ferring will co-promote MINIRINMELT® OD Tablet with Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin").
MINIRINMELT® OD Tablet is an oral formulation of desmopressin which allows convenient and reliable administration and which may be taken without water before bedtime. Since its initial approval in Denmark in February 2005, it has been approved for the indication of nocturnal enuresis / bedwetting in over 70 countries worldwide as of February 2012 including European countries. This formulation also provides enhanced administration compared to Desmopressin intranasal formulation for specific sub-populations such as pediatric patients.
Ferring and Kyowa Hakko Kirin will continue to co-promote existing products of "Desmopressin spray 10 Kyowa" for treatment of nocturnal enuresis / bedwetting, "Desmopressin Intranasal 0.01% Kyowa" and "Desmopressin spray 2.5 Kyowa" for treatment of central diabetes insipidus, and "Desmopressin injection 4 Kyowa" for treatment of hemophilia A with factor 8 / von Willebrand disease.
Although the prevalence rate of nocturnal enuresis / bedwetting is as high as 7% in children 6 to 14 years old seriously troubling many patients and their families, the number of patients actually receiving treatment at medical facilities is estimated to be very small compared to those in European countries. We expect that introduction of MINIRINMELT® OD Tablet will contribute to improving QOL for those patients suffering from nocturnal enuresis / bedwetting and their families.
Product characteristics of MINIRINMELT® OD Tablet
|1.||First oral formulation of desmopressin developed in Japan|
|2.||Orally disintegrating tablet that may be taken without water|
|3.||Highly recommended treatment drug of nocturnal enuresis / bedwetting being positioned as first-line therapy by ICCS (International Children's Continence Society). Also, it is granted Grade A and Evidence Level 1 recommendation by ICT (International Consultation on Incontinence)|
Product profile of MINIRINMELT® OD Tablet
|Product Name||MINIRINMELT® OD Tablet 120μg / 240μg|
|Generic Name||JAN: Desmopressin Acetate Hydrate|
|Date of Approval||March 30, 2012|
|Indication||Nocturnal enuresis / bedwetting associated with decrease in urine osmolarity or urine specific gravity|
|Dose and Administration||Usual dose is 120μg of desmopressin administered orally once daily before bedtime. If this dose is not sufficiently effective, the dose may be increased up to 240μg of desmopressin administered orally once daily before bedtime.|
|NHI drug price||197.1 yen for 120μg, 331.2 yen for 240μg|
Desmopressin is a synthetic analog of antidiuretic hormone (vasopressin), an artificial peptide consisting of 8 amino acids. The drug has a strong antidiuretic action that concentrates the urine and decreases urine output.
About nocturnal enuresis / bedwetting
Nocturnal Enuresis is caused in association with miscellaneous factors including abnormal amount of urine produced at night, bladder capacity and sleeping patterns. Children over the age of 5-6 who have not become dry at night and continue to wet the bed at least several times a month are considered to be suffering from nocturnal enuresis / bedwetting. It is said that 10% of 6-year olds, 5% of 10-year olds, and 2% of 16 year olds children (7% in total) are suffering from the disease.