Eton Pharmaceuticals announced U.S. Food and Drug Administration approval of Khindivi (hydrocortisone) Oral Solution for replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.
Khindivi is the first U.S. Food and Drug Administration (FDA)-approved oral liquid formulation of hydrocortisone and is available in a 1 mg/mL concentration. The solution is designed to allow for precise, incremental dosing without the need for tablet splitting, refrigeration, mixing, or shaking.
The formulation offers a practical alternative for pediatric patients who require individualized titration or who are unable to swallow tablets. It may also be administered via gastric tube. The product is expected to launch commercially in the week of June 2, 2025, and will be distributed exclusively through Anovo, a specialty pharmacy. Eton Pharmaceuticals anticipates combined peak sales of Khindivi and Alkindi Sprinkle (hydrocortisone) oral granules to exceed $50 million annually.
Khindivi is intended to address longstanding clinical challenges associated with accurate hydrocortisone dosing in children. According to pediatric endocrinologists, the ability to titrate dosing in small increments is important to matching individual pharmacokinetic needs during growth. The product was developed and submitted for approval entirely by Eton Pharmaceuticals, which will also lead its commercialization through its existing pediatric endocrinology-focused team.
Khindivi's safety profile includes several boxed and non-boxed warnings. It is not approved for stress dosing and must not be used in patients under 5 years of age due to the risk of hyperosmolarity from inactive ingredients, including polyethylene glycol 400 and propylene glycol. Adverse reactions include risk of adrenal crisis, immunosuppression with supraphysiologic doses, psychiatric and ophthalmic events, gastrointestinal complications, growth suppression, and Cushing’s syndrome. Concurrent use with nonsteroidal anti-inflammatory drugs may increase the risk of gastrointestinal perforation. Khindivi is contraindicated in patients with known hypersensitivity to hydrocortisone or any components of the formulation.
Clinicians may prescribe Khindivi through e-prescription to Anovo or via fax referral. Additional prescribing information is available at www.khindivi.com. The Eton Cares Program will provide benefit verification, patient education, and financial support services, including copay assistance for eligible patients.
Source: Eton Pharmaceuticals