28 MAR 2013
The US FDA has cleared Eisai’s ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age.
The approval was based on positive data from multicenter, double-blind trial conducted in 127 pediatric patients between one to 11 years of age with GERD.
Eisai president and CEO Lonnel Coats said, “We are proud to offer a new treatment option for young children who suffer from GERD.”
The parallel-group study comprised a treatment period of 12 weeks and an extension period of two dose levels of rabeprazole for 24 weeks.
Healing was achieved in 81% of patients during the treatment period and 90% retained healing during the extension period.
The active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.43. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural formula is:
ACIPHEX is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
Inactive ingredients of the 20 mg tablet are carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, propylene glycol, sodium hydroxide, sodium stearyl fumarate, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating. Iron oxide red is the ink pigment.