Dipharma has developed 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.
“This achievement is another milestone in the expansion of our pipeline, aimed at improving the life of patients suffering from inborn errors of metabolism,” said Marc-Olivier Geinoz, CEO of Dipharma.
“We worked hard to develop an improved formulation meeting patients’ requirements – today our R and D efforts were rewarded with the confirmation that our new formulation is fast dissolving and stable at room temperature.”
Dipharma has also filed a patent application claiming new fast dissolving and stable tablet formulations of Carglumic acid, together with the technology to improve the product stability, without modifying the pharmaceutical form.
Carglumic acid formulation is the fourth Dipharma product approaching the market.
Diterin (sapropterin dihydrochloride 100mg 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 (nitisinone capsules) was submitted in EU in the last quarter of 2016 for the treatment of hereditary tyrosinemia type I.
Several other products for the treatment of rare metabolic diseases is ongoing.