Endocrine Abstracts

In 2015 AdrenalNET organized a roundtable conference with patient representatives, prescribers and pharmaceutical industry. The cause of this meeting was complaints of patients about the problematic hydrocortisone market in the Netherlands, characterized by frequent availability issues (shortage ) of the hydrocortison tablets/capsules and frequent changes in manufacturers (compounding companies) leading to quality issues. All parties at the roundtable meeting agreed to join forces to achieve hydrocortisone tablets with the following requirements:

1. Immediate release hydrocortisone tablets for both children and adults. Conventional IR-released hydrocortison remains the gold standard (EndoERN position paper 2021).

2. Various strengths ranging from 1 to 10 mg.

3. Colour coded tablets with no bad taste and no need for splitting anymore4. Permanent availability which will be increased by obtaining marketing authorization and by production of hydrocortison tablets in the EU from preferable European raw materials. In 2018 one of our partners, a small Dutch pharmaceutical company, started the development of new hydrocortison tablets based on the above requirements. Despite a lot of regulatory struggles, in March 2020 registration was approved in the Netherlands for the 1,5 and 10 mg tablets, followed by recent registration (2021) of the 2 and 3 mg hydrocortison. The different strengths make it possible to mimic the individual patient’s cortisol pattern during the day most closely. The introduction of the new tablets was followed by a fast-uptake in the market. At the moment expansion of these hydrocortison tablets to other European countries will take place. This project is a good example of fruitfull collaboration between patients, doctors and pharmaceutical companies which deserves a rollout over the rest of Europe. AdrenalNET and Endo-ERN may serve a important role in achieving this.