Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI SPRINKLE (hydrocortisone) in the United States - Seite 2

About Pediatric Adrenocortical Insufficiency
Pediatric adrenocortical Insufficiency (AI) is a relatively rare disease characterized by an inability to synthesize and release cortisol, and sometimes aldosterone. When due to congenital adrenal hyperplasia (CAH), the most common form of pediatric AI, there will also be excessive androgens (resulting in masculinized external genitalia in affected females and, without proper treatment, the potential for precocious puberty, premature growth termination, and short stature in both sexes). Patients with primary or central (secondary and tertiary) AI lack appropriate levels of cortisol in their system. Diminished cortisol in the system may result in deadly consequences such as adrenal crisis. To survive, patients with AI must replace the missing cortisol daily. Eton estimates that pediatric AI affects between 5,000 and 11,000 children in the United States.

About ALKINDI SPRINKLE
ALKINDI SPRINKLE is an immediate-release oral hydrocortisone granule preparation that has been specifically designed to meet the dosing needs of pediatric patients with adrenocortical insufficiency. Prior to ALKINDI SPRINKLE’s approval, parent caregivers have had to cut or split higher-strength hydrocortisone tablets to achieve the lower doses required for small children, which could result in inaccurate dosing. ALKINDI SPRINKLE is manufactured using commercially proven technology in four strengths: 0.5 mg, 1 mg, 2 mg and 5 mg, to give greater dosing flexibility to clinicians. Taste-masking excipients that are acceptable for pediatric use eliminate the bitter taste of hydrocortisone. ALKINDI SPRINKLE has a shelf -life of three years at ambient temperature and does not require refrigeration.

Indications and Usage
ALKINDI SPRINKLE is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.

Important Safety Information

Contraindications

ALKINDI SPRINKLE is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. Anaphylactic reactions have occurred in patients receiving corticosteroids.

Warning and Precautions

• Adrenal Crisis: Undertreatment or sudden discontinuation of therapy may lead to adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events such as infections or surgery. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations.