March 25, 2013
Launch of "MINIRINMELT® OD Tablet 60μg"
A Treatment of Central Diabetes Insipidus
Tokyo, Japan, March 25, 2013 --- Ferring Pharmaceuticals Co., Ltd. (hereinafter "Ferring") (Headquarters: Minato-ku, Tokyo; President and Representative Director: Mark Noggle) and Kyowa Hakko Kirin Co., Ltd. (hereinafter "Kyowa Hakko Kirin") (Headquarters: Chiyoda-ku, Tokyo; President and CEO: Nobuo Hanai) announced the launch of "MINIRINMELT® OD Tablet 60μg" (generic name: desmopressin acetate hydrate) (hereinafter "the drug") for the treatment of central diabetes insipidus on March 25 following the marketing approval granted on December 25, 2012 and the NHI drug price listing on February 22, 2013. With MINIRINMELT® OD Tablet 120μg / 240μg approved for additional indication on December 21, 2012, three dosages are now available for treatment of central diabetes insipidus.
Prescription restriction imposed on the drug (maximum of 14 days' supply per prescription) will be lifted on 31 May, 2013, the same day when the ongoing prescription restriction on MINIRINMELT® OD Tablet 120μg / 240μg, which were launched on May 2012 for treatment of bedwetting/nocturnal enuresis followed by approval for additional indication of central diabetes insipidus in December 2012, will be lifted (Notification Ref#0222-5).
Ferring and Kyowa Hakko Kirin will co-promote the drug with Ferring being the Manufacturer and Marketing Approval Holder and Kyowa Hakko Kirin being the distributor.
MINIRINMELT®OD Tablet is an orally disintegrating formulation of desmopressin which allows convenient and reliable administration and may be taken without water. Since its initial approval in Finland in February 2005, it has been approved in approximately 70 countries worldwide as of March 2013.
Since central diabetes insipidus is an intractable disease, the treatment endpoint is to normalize patients' life freeing them from physical and social restraints with adverse effect of desmopressin suppressed to the minimum level. While the conventional intranasal formulation, which was previously the only available formulation, has certain issues such as its inconvenience in terms of portability as well as unstable efficacy associated with decreased absorption rate in complications including rhinitis, newly launched MINIRINMELT® OD Tablet provides enhanced administration solving such issues.
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. When administered to patients with central diabetes insipidus whose symptoms had been under control by desmopressin intranasal preparations (rhinyle solution, spray), MINIRINMELT® OD Tablet demonstrated equivalent effect in controlling pharmacodynamic parameters (volume of urine output in 24 hours, urine osmolarity, urine specific gravity).
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 central diabetes insipidus
Central diabetes insipidus is a disease caused by reduced or absent synthesis or secretion of antidiuretic hormone known as arginine vasopressin (AVP) that causes symptoms such as excessive urination as well as extreme thirst and increased fluid intake. According to the outcome of a nationwide survey reported by the Ministry of Health and Welfare's (current Ministry of Health, Labor and Welfare's) Research Group on Intractable Disease of Pituitary Dysfunction in 1996, the number of central diabetes insipidus patients was estimated to be approximately 4,700, although the number of such patients today is considered to be about 7,000 to 10,000 considering the number of relevant prescriptions of Desmopressin intranasal preparation.
Kyowa Hakko Kirin