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Role of carglumic acid in the treatment of acute hyperammonemia due to N-acetylglutamate synthase deficiency.
announces the successful development of a new, fast dissolving formulation of Carglumic acid tablets stable at room temperature.
Carglumic acid is a key therapeutic tool in the management of rare, life threatening inborn metabolic disorders affecting the urea cycle; as such it was a natural candidate for the Company's products portfolio.
also announces the filing of a patent application claiming new fast dissolving and stable tablet formulations of Carglumic acid, together with the proprietary technology developed to improve the product stability, without modifying the pharmaceutical form the patients are familiar to.
Carglumic acid formulation is the fourth Dipharma product approaching the market: Diterin (sapropterin dihydrochloride 100 mg tabs) has already been approved in South Korea and Russia for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), Miglustat (miglustat 100 mg caps) was submitted in the USA through an abbreviated new drug application (ANDA) in 2016 for the treatment of Gaucher disease and Disanit[R] (nitisinone capsules) was submitted in EU in the last quarter of 2016 for the treatment of hereditary tyrosinemia type I.
The three endocrine products are carglumic acid (Carbaglu; C) for treatment of hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS); tesamorelin (Egrifta; X) a growth hormone--releasing factor analog for reduction of excess abdominal fat in HIV-infected patients; and velaglucerase alfa (VPRIV; B) given for long-term enzyme replacement in patients with Gaucher disease.