ISICORT® ‒ a fast-dissolving oral film
AcuCort’s ISICORT®, previously named Dexa ODF (Oral Dissolvable Film), is a new and smart patented drug (approved in Sweden) for the treatment of acute allergic reactions, croup and chemotherapy-induced nausea and vomiting (CINV). The fast-dissolving oral film contains the glucocorticoid dexamethasone which is a well-known, often used and well-documented anti-inflammatory substance.
ISICORT® is a thin, fast-dissolving, user-friendly oral film that melts om the tongue. It does not need to be swallowed and does not require water. The film is contained in a small and convenient package designed to always be carried with you.
AcuCort has developed a fast-dissolving oral film containing the well-documented glucocorticoid dexamethasone, which is used by allergy sufferers, among others, but in a new innovative administration form. In EU and the US alone there are at least 25 million people suffering or at risk of suffering acute and severe allergic reactions from e.g. food or insect stings, but also from pollen or other allergens.
Allergic reactions can occur suddenly and then ISICORT® is an excellent alternative as the package is no bigger than a business card thus easy to always carry with you. The oral film dissolves quickly when it is placed on the tongue and the medical effect is activated. This is in marked contrast to tablets that should be dissolved in water before swallowing, which can be very cumbersome in an acute situation.
One oral film is one dosage
In acute or emergency situations the concept – one oral film = one dose – simplifies the administration and could ease the stress associated with acute situations.
AcuCort has conducted two bioequivalence studies; partly as “proof of concept” (a concept proof of the drug’s effect in humans), and partly for the application of market approval in the EU (2018) which show that the effect of the fast-dissolving oral film ISICORT® is comparable to the corresponding dose of dexamethasone in tablet form. The studies also indicate that the oral film gives just over 20 percent faster absorption of the active substance.
AcuCort’s ISICORT® is protected by two patent families (approved patents and patent applications) and considerable technical know-how concerning dexamethasone and oral films.
The Allergy Market
One in five has allergic symptoms
Allergy is a condition that affects more than 20 percent of the global population. In Sweden, the most common allergies are seasonal pollen allergy and perennial allergy to furred animals. The most common symptoms are tiredness, runny nose, nasal congestion, itching eyes and sneezing.
Some allergies tend to elicit stronger reactions and symptoms. This applies to some forms of food allergy (e.g. peanuts, shellfish and milk) which are more common among children than adults. There are also groups of people allergic to insect stings (bee and wasp) and those who are allergic to various types of medicines, e.g. penicillin. Symptoms cover a wide range from nettle rash, swelling and itching of the eyes, nose, mouth and throat and nausea, to ‒ in serious but luckily rare cases ‒ anaphylactic shock, which is a potentially life-threatening condition where the airways are choked and serious circulation problems can develop.
Focus on acute and severe allergic reactions
ISICORT® is intended for persons at risk for acute and severe allergic reactions. The prevalence of the symptoms described above may be as high as 10 percent of the population, but there is an overlap, as you may be allergic to more than one substance. In all, AcuCort has estimated the prevalence for the company’s target group to 3 percent. This corresponds to some 25 million people in the EU and the US.
Treatment varies from country to country depending on guidelines and recommendations. Mild allergic symptoms are often handled with prescription-free antihistamine drugs. The next step in the treatment ladder is to see a general physician or an allergy specialist who often prescribes stronger doses of antihistamine and/or various topical or oral glucocorticoids. When a patient is considered to be at risk for anaphylactic reactions, also injection pens with adrenaline can be prescribed by the patient’s physician. In case of anaphylactic shock, which is a lie threatening condition, the patient shall inject the prescribed adrenaline and seek emergency medical care.
Acute medicine and “rescue product”
The drug ISICORT® is an acute medicine and “rescue product” for persons who are at risk for acute and severe allergic reactions where the risk for anaphylactic shock is considered to be low. Glucocorticoids also have a role as a complement to the injection of adrenaline for treatment of anaphylactic shock. (1), (2), (3)
ISICORT® aims to fill the same medical role as the existing glucocorticoids, which are approved already today, i.e. tablets and solutions containing dexamethasone, betametason, prednisolone or prednisone. In addition, ISICORT® may become the new, fast and patient-friendly treatment option among glucocorticoids as the oral film can always be available and can be used anywhere and whenever the need arises.
For acute allergic reactions
When an allergic reaction occurs or a person is at risk for suffering such a reaction you want something that helps quickly and is immediately available.
- ISICORT® comes in a thin, small package that fits in the wallet, the cell phone cover or credit card holder. The new innovative product is available whenever it is needed, whether you are at home or away.
- The 4 mg, 6 mg and 8 mg doses of the oral films are in line with recommended doses at acute allergic reactions, i.e. one oral film = one dose. The affected person thus does not have to administer several tablets to reach the same dosage.
- In contrast to tablets, no water is needed for taking ISICORT®. Together with the practical size of the package and the fact that the patient only needs to take one oral film this means that ISICORT® can be used anywhere and whenever needed.
- When the oral film is placed in the oral cavity it is completely dissolved within 10-15 seconds and the active substance begins to be absorbed immediately. During these seconds the oral film is slightly adhesive and can therefore, unlike a tablet, not be spitted or coughed out, e.g. by a panicking child.
- ISICORT® reaches maximum absorption of dexamethasone in plasma, T(max), just over 20 percent faster (p=0.0575) than a Fortecortin® tablet. Fast absorption and effect is essential in an acute situation.
The global market for allergy pharmaceuticals was considered to be worth billion USD 27 in 2016 and is estimated to grow with 6 percent annually (4). ISICORT® will primarily compete with other forms of glucocorticoids and be a complement to antihistamine products and adrenaline injectors. The global allergy market for glucocorticoids was estimated to billion USD 3.1 in 2016 and is estimated to grow with 6 percent annually to 2025 (4).
As far as AcuCort can tell, there is no other glucocorticoid today that has the same administration form and offers the same benefits as ISICORT®. The company therefore aims upon registration at marketing ISICORT® as a premium product and at a significantly higher price than conventional tablets.
AcuCort estimates the annual sales potential for ISICORT® in allergy to be up to MEUR 180 in the EU and the US of which 60-65 percent should accrue to AcuCort and commercializing partners. The rest is calculated to cover costs for distribution and pharmacies.
Other potential indications
AcuCort has identified two further indications where ISICORT® may be competitive: croup in children and chemotherapy-induced nausea and vomiting (CINV).
Croup in children
Croup (laryngotracheobronchitis) are common childhood illnesses characterized by a swelling of the area below the vocal chords, generally triggered by a cold. Typical symptoms are barking cough, hoarseness, wheezing and shortness of breath.
Approximately 3 percent of all children up to the age of 6 are affected annually (5). Croup attacks cause much stress and anxiety in children and parents and account also for 5 percent of the hospitalizations in this age group (6).
Single doses of 0.15-0.6 mg dexamethasone per kilo body weight are considered the standard treatment. It may be required that AcuCort develops some additional strength, e.g. 2 mg, in order to handle dosing for smaller children. ISICORT® would offer major benefits in the treatment of croup, e.g.:
- Rapid uptake of the active substance. At a croup attack rapid effect is important and studies show that dexamethasone gives effect already after 30 minutes (9). The faster T(max) that ISICORT® has demonstrated in the clinical study AcuCort001 may be a further advantage.
- ISICORT® cannot be spitted out or coughed up at a croup attack or by a stressed child who may be panicking.
AcuCort estimates the annual sales potential for ISICORT® in the croup in children indication in the EU and the US to MEUR 10 is up to at the pharmacy level.
Chemotherapy induced nausea and vomiting (CINV)
Chemotherapy is an important treatment for cancer patients. One of its most frequent side effects is CINV, which affects some 70-80 percent of all persons receiving chemotherapy. CINV is very unpleasant for the patients and can lead to a premature termination of the chemotherapy.
There are a number of pharmaceuticals used to prevent and treat CINV. Examples include 5-HT3 receptor antagonists, NK1 receptor antagonists and glucocorticoids. Dexamethasone is the clearly specified glucocorticoid option in the Antiemetic Guidelines 2010 (8). Dexamethasone can be used a single treatment at low risk for CINV, and as a complement to other drugs when the risk for CINV is higher.
As dexamethasone is also used in other cancer related contexts oncologists are used to prescribing and using the substance. ISICORT® would have major competitive advantages compared to traditional tablets:
- Easy to use, does not require water.
- Does not require active swallowing, as it dissolves in the mouth and is rapidly absorbed, which is important as some cancer patients may have swallowing difficulties.
AcuCort estimates the annual potential for ISICORT® in CINV in the EU and the US to MEUR 20-40.
- Lieberman et al. Anaphylaxis – a practice parameter update 2015. Annals of Allergy, Asthma, Immunology 115 (2015) 341-384
- Mustafa S.S. Anaphylaxis treatment and management March 2014
- Lars Gottberg et al. Anafylaxi Rekommendationer för omhändertagande och behandling. SFFA 2015
- Grand View Research, Allergy therapeutics market analysis and segment forecasts to 2025
- Bjornson et al. A randomized trial of single dose of dexamethasone for mild croup. N.E.J.M 2004;351:1306-13
- Johnson D W. Croup, Clin. Evidence (online) 2009:0321
- Dobrovoljac M (1), Geelhoed GC. How fast does oral dexamethasone work in mild to moderately severecroup? Emerg. Med Australas. 2012 Feb;24(1):79-85
- Antiemetic Guidelines 2010 of the MASCC Antiemetic Study Group