About the project
Potent glucocorticoids such as prednisolone, prednisone and dexamethasone are used in a very large number of conditions for their anti-inflammatory or immunosuppressive effects. For example, acute allergic conditions, various dermatological and autoimmune diseases, treatment of cerebral oedema, and for prophylaxis and treatment of nausea and vomiting induced by chemotherapy (CINV). In addition, they are indicated or suggested for a number of conditions in which their precise mechanisms-of-action are not fully understood.
According to AcuCort’s estimates, the total prevalence for the indications for these oral glucocorticoids is at least 5%, which means almost 50 million people only in Europe and North America.
Glucocorticoids have been used for many decades and their effects, side effects, and dosing schedules are well-known. They are available in numerous products and dosage forms, for example tablets, injections, implants and creams, as well as in fixed combination products with other drugs, e.g., antibiotics.
In many of these treatments, for example acute allergic conditions, a rapid and convenient oral administration is desired. However, despite the widespread use of oral glucocorticoids, only conventional tablets are available today, which have the drawback of being rather bulky, requiring drinking water and being unsuitable for use in unconscious or panic struck patients and in particular children. Cancer patients suffering from nausea and vomiting is another patient population for which the conventional tablet is not the optimal dosage form.
That is why AcuCort is developing a new product that could make a difference for millions of patients and their relatives. Same effect, revolutionary administration.
About the product
During development work in another project, the innovators behind AcuCort identified a need for a convenient, easy-to-use, efficient glucocorticoid product and realized that there was no such on the market. They also saw a need for the product being administered by a person without any medical training helping the patient, such as a parent, friend or informal caretaker. A thin, dissolvable film to be placed in the mouth containing a certain safe and effective glucocorticoid was envisioned and a new development project was started.
That product has now been developed and a batch manufactured according to GMP requirements has been studied in a phase I study of safety and pharmacokinetics with 30 healthy volunteers. As desired and expected by AcuCort, that study showed that the product is safe, easy to use, bioequivalent and will give the same desired effects as a conventional tablet. In addition, the systemic uptake of the glucocorticoid was faster than for a tablet.
The product does not contain any additives and has been shown not to be irritating to the oral mucosa. It will be presented in a convenient package with just a few units in each, to facilitate to bring them along to ensure that when needed, it’s there.