Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI SPRINKLE (hydrocortisone) in the United States
- ALKINDI SPRINKLE is now exclusively available through AnovoRx Specialty Pharmacy. To support patient access to ALKINDI SPRINKLE, Eton has established the Eton
DEER PARK, Ill., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI SPRINKLE for sale and distribution in the United States. The U.S. Food and Drug Administration (FDA) has approved ALKINDI SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age. ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children.
ALKINDI SPRINKLE will be available exclusively through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program will complete prescription fulfillment, insurance benefits investigation, educational support, aid qualified patients to obtain financial assistance along with other services designed to help patients access treatment. To enroll patients in the program and prescribe ALKINDI SPRINKLE, clinicians will need to complete a patient referral form available at www.alkindisprinkle.com.
“ALKINDI SPRINKLE is a very welcome treatment option for children who, for over 60 years, were forced to rely on adult-strength hydrocortisone to treat adrenocortical insufficiency,” said Mitchell
Geffner MD, co-director, Congenital Adrenal Hyperplasia (CAH) Comprehensive Care Clinic and Professor of Pediatrics, Keck School of Medicine of University of Southern California. “Low-dose options,
as low as 0.5 mg, allow for more accurate and individualized dosing for patients.”
The FDA approval of ALKINDI SPRINKLE was supported by six clinical studies, including the first and only interventional Phase III study of oral hydrocortisone for Pediatric AI in neonates to children under eight years of age. ALKINDI SPRINKLE achieved significant increases in cortisol levels from baseline (P<0.0001) and was found to be well tolerated with no serious adverse events. Prior to the approval of ALKINDI SPRINKLE, oral hydrocortisone was only FDA-approved in tablet formulations of 5 mg and stronger. Many pediatric patients require significantly lower doses and the flexibility of precision titration. ALKINDI SPRINKLE will be available in 0.5-mg, 1-mg, 2-mg, and 5-mg strengths, allowing clinicians greater flexibility to individualize dosing based on each patient’s needs in accordance with the instructions for dosage and administration.
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