Date: 2026-05-06 (source update: 2026-06-25)
Source: Addison’s Disease Self-Help Group (ADSHG) — https://www.addisonsdisease.org.uk/news/efmody-approved-uk
What happened?
On 6 May 2026 the UK medicines regulator, the MHRA, approved Efmody (modified-release hydrocortisone) for the indication of adrenal insufficiency. The medicine is therefore licensed in the United Kingdom not only for congenital adrenal hyperplasia (CAH) but for all forms of adrenal insufficiency, including Addison’s disease.
A similar indication expansion has also been reported in Europe (EU approval). The medicine is not licensed for this use in the United States. This item is based on ADSHG’s summary for the patient community.
What is Efmody? (brief background)
Efmody is a “modified-release” form of hydrocortisone. The aim is a release profile closer to the body’s natural cortisol rhythm. According to ADSHG, typical use follows a night-plus-morning pattern sometimes called the “toothbrushing” schedule; details and suitability depend on a clinician’s decision.
The capsule is designed not to break down immediately in the stomach; release occurs in the small intestine. This text does not recommend changing your medicine; it only summarises a public patient-charity news item.
Research summary (CHAMPAIN)
ADSHG cites the CHAMPAIN study published in a Lancet family journal (eClinicalMedicine, January 2026). The study compared two modified-release hydrocortisone approaches in adults with primary adrenal insufficiency.
The primary measure was early-morning (around 07:00) serum cortisol. The study reported a clear difference in favour of the formulation that better captured the early-morning cortisol rise. Secondary measures also reported improvement in the same direction on most fatigue and quality-of-life questionnaires.
These results are encouraging, but they summarise a single study; they do not mean the same approach applies to every patient. Decisions belong with your endocrinologist’s assessment.
Who is it being considered for?
ADSHG states clearly that Efmody was not developed as a first-line (first-choice) medicine. In the United Kingdom, immediate-release hydrocortisone is described as the preferred glucocorticoid approach in adrenal insufficiency (in the context of NICE 2024).
Clinical guidance is still clarifying “for whom, and when.” According to ADSHG, it may come up for people who have ongoing symptoms that seriously affect quality of life on their current replacement, and whose clinician is considering an alternative. Licensed age: 12 years and older (ADSHG note for the UK and EU).
Access and cost (United Kingdom context)
ADSHG writes that the annual cost, under an average-dose assumption, is markedly higher than for immediate-release hydrocortisone. The prescribing route can vary by region (ICB / funding); special prescription, individual funding requests, or formulary addition are among the paths described. These processes differ from Türkiye’s licensing and reimbursement system.
This news item does not cover whether the medicine is licensed, available, or reimbursed in Türkiye. Ask your own endocrinologist about local options.
What does this mean for patients in Türkiye?
This is a summary of a UK / EU regulatory development; it does not mean an automatic medicine change or a new standard of care in Türkiye. It does show that research into a “more physiological cortisol profile” in adrenal insufficiency is moving faster.
You can raise points that matter to you (morning fatigue, quality of life, alternative formulations) at your next endocrinology appointment. Any dose or medicine change is planned only with your doctor.
Warning: This is a news summary; it is not dose or treatment advice. Ask your endocrinologist.
Medical disclaimer: Information on this site is prepared by a patient community for general information only; always consult your own doctor (endocrinologist) about diagnosis, treatment or any dose change. In an emergency in Türkiye, call 112.