Dexa ODF

Dexa ODF ‒ a fast-dissolving film

AcuCort’s Dexa ODF (Oral Dissolvable Film) is a new and smart patented product for the treatment of acute allergic reactions, croup and chemotherapy-induced nausea and vomiting (CINV). The fast-dissolving film contains the glucocorticoid dexamethasone which is a well-known, often used and well-documented anti-inflammatory substance.
Dexa ODF is a thin, fast-dissolving, user-friendly 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.

Medical need

AcuCort has developed a fast-dissolving 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 at risk for suffering severe allergic reactions from e.g. food or insect stings.

User friendly

Allergic reactions can occur suddenly and then Dexa ODF is an excellent alternative as the package is no bigger than a business card thus easy to always carry with you. The 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 film is one dosage

In acute or emergency situations the concept – one film = one dose – simplifies the administration and could ease the stress associated with acute situations.

Faster uptake

AcuCort has carried out a so-called bioequivalence study showing that the effect of the fast-dissolving film Dexa ODF is comparable to the corresponding dose of dexamethasone in tablet form. The study also shows that the film gives a 23 percent faster absorption of the active substance.

Intellectual property

AcuCort Dexa ODF is protected by two patent families (approved patents and patent applications) and a considerable amount of 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 allergic reactions

Dexa ODF is intended for persons at risk for acute allergic reactions. The prevalence of the symptoms described above may be as high as 10 percent, but there is an overlap, as you may be allergic to more than one substance. It is also a question of the severity of previous reactions, etc. In all, AcuCort has conservatively 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.

Clinical practice

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, injection pens with adrenaline can be prescribed by the patient’s physician. In case of anaphylactic shock the patient shall inject the prescribed adrenaline and seek emergency medical care.

Market positioning

Acute Medicine and “Rescue Product”

Dexa ODF is an acute medicine and “rescue product” for persons who are at risk for acute 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)

Dexa ODF aims to fill the same medical role as the existing glucocorticoids, i.e. tablets and solutions containing dexamethasone, prednisolone or prednisone. In addition, Dexa ODF is the new, fast and patient-friendly treatment option among glucocorticoids as the 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.

  • Dexa ODF 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 and 8 mg doses of the films are in line with recommended doses at acute allergic reactions, i.e. one 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 Dexa ODF. Together with the practical size of the package and the fact that the patient only needs to take one film this means that Dexa ODF can be used anywhere and whenever needed.
  • When the 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 film is slightly adhesive and can therefore, unlike a tablet, not be spitted or coughed out, e.g. by a panicking child.
  • Dexa ODF reaches maximum absorption of dexamethasone in plasma, T(max), 23 percent faster (p=0.0575) than a tablet. Fast absorption and effect is essential in an acute situation.

Market potential

The global market for allergy products including diagnostics and various types of pharmaceutical treatments was considered to be worth billion USD 35.3 in 2015 and is growing by 5 to 6 percent annually (4). Dexa ODF will primarily compete with other forms of glucocorticoids and be a complement to antihistamine products and adrenaline injectors. It is difficult to calculate how large share of the total market that consists of glucocorticoids, but we know that in 2013 some 44 million doses of 4 mg dexamethasone tablets were sold in the UK and Germany. Another indication of the size of the market is that some 12.4 million adrenaline injection pens were expected to be sold in 2015 (5).
As far as AcuCort can tell there is no other glucocorticoid today that has the same administration form and offers the same benefits as Dexa ODF. The company therefore aims at marketing Dexa ODF as a premium product and at a significantly higher price than conventional tablets.

AcuCort estimates the annual sales potential for Dexa ODF 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 Dexa ODF may be competitive: croup in children and chemotherapy-induced nausea and vomiting (CINV).

Croup in children

Croup (laryngotracheobronchitis) is a common childhood illness 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.

Approx. 3 percent of all children up to the age of 6 are affected annually (7). Croup attacks cause much stress and anxiety in children and parents and account also for 5 percent of the hospitalizations in this age group (8).

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. Dexa ODF 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 Dexa ODF has demonstrated in the clinical study AcuCort001 may be a further advantage.
  • Dexa ODF 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 Dexa ODF in the croup indication in the EU and the US to MEUR 15 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 (10). 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. Dexa ODF 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 Dexa ODF in CINV in the EU and the US to MEUR 20-40.

References

  1. Lieberman et al. Anaphylaxis – a practice parameter update 2015. Annals of Allergy, Asthma, Immunology 115 (2015) 341-384.
  2. Mustafa S.S. Anaphylaxis treatment and management March 2014.
  3. Lars Gottberg et al. Anafylaxi Rekommendationer för omhändertagande och behandling. SFFA 2015.
  4. BCC research. Global Allergy Diagnostic and Treatment Market, March 2015.
  5. Larry Smith SmithOnStock http://smithonstocks.com/antares-settlement-of-litigation-onepipen-is-a-positive-ais-3-08/
  6. www.GoodRx. Prisjämförelse februari 2016.
  7. Bjornson et al. A randomized trial of single dose of dexamethasone for mild croup. N.E.J.M 2004;351:1306-13
  8. Johnson D W. Croup, Clin. Evidence (online) 2009:0321.
  9. 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.
  10. Antiemetic Guidelines 2010 of the MASCC Antiemetic Study Group.