May 20, 2014
Kissei Pharmaceutical Co., Ltd. submits a public knowledge-based application for a respiratory stimulant DOPRAM® injectable 400mg for the additional indication of an apneic attack of prematurity
Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; President and CEO: Mutsuo Kanzawa ("Kissei")] announced today that, Kissei has submitted a public knowledge-based application on May 20, 2014 for a respiratory stimulant DOPRAM® Injectable 400mg (generic name: doxapram hydrochloride hydrate, Japanese Pharmacopoeia) for the additional indication of an apneic attack of prematurity.
Kissei has received an urgent request from healthcare professionals to develop an additional indication of the drug to treat apneic attacks of prematurity; the company has been in consultation with Japan's Ministry of Health, Labour, and Welfare (MHLW) since April 2012. The MHLW has determined that the public knowledge-based application was applicable to that indication, leading to the present application for an additional indication.
Kissei expects this application to provide a new treatment option for patients and healthcare professionals. Kissei will further contribute to improved healthcare by actively promoting the authorization of currently unapproved drugs and indications, following the launch, in April 2014, of the SAVENE® Injectable 500mg (publicly offered to companies for development by the review committee on "unapproved new drugs/indications with high medical needs"). This mission reflects the company's policy statement, "Kissei contributes to society through valuable and innovative medicines."
-Apnea of prematurity-
Apnea of prematurity is characterized by respiratory pauses that last for at least 20 seconds or by respiratory pauses that last for less than 20 seconds but are accompanied by bradycardia (<100 beats/min) or cyanosis in infants born after less than 37 weeks of gestation, with no underlying disorders that cause apnea. The risk increases with earlier gestational age; it is about 25% in preterm infants and almost all in infants born at less than 28 weeks gestational age.
-Application Based on Evidence Already in the Public Domain-
This application category applies to cases where the efficacy and safety of the off-label use (e.g., indication) of a drug have been confirmed by medical and pharmaceutical knowledge in the public domain, allowing an application for the addition of a particular off-label use to be submitted without the need for a complete or partial clinical trial program.
-SAVENE® Injectable 500 mg-
This is the first drug approved in Japan for the treatment of anthracycline extravasation. As of January 2014, it has been approved in 33 countries including Japan.