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March 20, 2015

Kissei Pharmaceutical Co., Ltd. Receives Approval in Japan for Additional Indication and Dosage and Administration of DOPRAM® Injectable 400mg for Primary Apnea in Premature and Low-Birth-Weight Infants (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 it has received approval in Japan for a supplemental New Drug Application (NDA) of a respiratory stimulant DOPRAM® Injectable 400mg (generic name: doxapram hydrochloride hydrate, Japanese Pharmacopoeia) for an additional indication and dosage and administration of an apneic attack of prematurity after submitting an application with public knowledge.

Kissei had received an urgent request from healthcare professionals to develop an additional indication of the drug to treat apneic attacks of prematurity, and submitted the supplemental NDA for an additional indication of DOPRAM® in May 2014.

Kissei expects this approval to provide a new treatment option for patients and healthcare professionals.


≪Reference≫
Indication, Dosage and Administration (about apneic attack of prematurity)


Indication
Primary apnea in premature and low-birth-weight infants (apneic attack of prematurity), only when the desired effect is not obtained on treatment with xanthine preparations.

Dosage and Administration
Primary apnea in premature and low-birth-weight infants
(apneic attack of prematurity):
Usually, doxapram (1.5 mg/kg) is administered as an intravenous infusion over 1 h. This is followed by a continuous intravenous infusion of doxapram at 0.2 mg/kg/h. If the initial dose is ineffective, the dose should be increased to 0.4 mg/kg/h.


Primary apnea in premature and low-birth-weight infants (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, affecting about 25% of preterm infants and almost all infants born at less than 28 weeks of gestation.

Application with public knowledge
This application category is applicable to cases in which 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.