Odactra the first sublingual house dust mite allergen, has been approved by the FDA. Odactra will be administered under the tongue and it is used to treat house dust mite induced perennial allergic rhinitis and/or allergic conjunctivitis for adults 18-65 years of age.
House dust mite is one of the most common perennial aeroallergens affecting millions of people around the world. Odactra will provide an alternative treatment for people allergic to house dust mites who do not want use medications and for patients who do no want to do allergy shots to help address their symptoms.
House dust mites are microscopic insects found commonly in house dust. They are commonly found in mattresses, pillows, carpets, rugs, curtains, drapes and upholstered furniture. You can not see them with the naked eye and they do not bite you. Common symptoms of dust mite allergy are cough, runny nose, itching of the nose, nasal congestion, sneezing and itchy/watery eyes. An allergist can do a simple allergy skin test in the office to see if you are allergic to dust mites, blood testing is also available. Environmental control recommendations commonly include, encasings for mattresses and pillows, removing carpets and rugs, using a HEPA air filter and washing all bedding in hot water. Despite these measures, many patients still have allergy symptoms.
For many years allergists have been giving allergy shots to patients with house dust mite allergies. Odactra would be an alternative for patients who can not undergo allergy shots (subcutaneous immunotherapy). Odactra would join grass and ragweed sublingual immunotherapy tablets that are already on the market.
Odactra is a once-daily tablet taken every day, year round. Odactra rapidly dissolves after it is placed under the tongue. The first dose is taken under the supervision of a health care professional with experience in allergy symptoms. The patient has to be observed for 30 minutes to monitor for adverse reactions. If the first dose of Odactra is well tolerated, the remaining daily dosages can be taken at home. Merck is the manufacturer of Odactra, they report that it may take 8-14 weeks of daily dosing to see an actually benefit.
The early studies of Odactra showed patients experienced a 16-18 percent reduction in symptoms and the need for additional medications compared to placebo. Sublingual immunotherapy generally does not see as good results as subcutaneous immunotherapy (allergy shots), but it is more convenient and there is less of a chance of having systemic side effects such as anaphylaxis. The most common side effects seen with Odactra are nausea, itching of ears and mouth and swelling of the lips and tongue. All patients who receive Odactra will need to be prescribed an epinephrine auto-injector in case of an emergency.
A common question that allergists are often asked is which is more effective, allergy shots or allergy drops (tablets)? We addressed this issue in a previous blog post. The conclusion was that allergy shots were generally more effective and had better overall efficacy, but the convenience was easier for sublingual therapy and there were less side effects. There were no head to head studies of Odactra versus standard allergy dust mites shots.
It remains to be seen how effective Odactra will be when people start taking it, but it will be a good alternative for patients who do not want to take allergy medications or for those who can do allergy shots because of either time, travel, cost or inconvenience.
The price and insurance coverage for Odactra have yet to be decided. Usually when a new medication such as Odactra comes out, the insurance coverage is very minimal and the manufacturer provides coupons for patients to help cover the cost of the medication. Look for Merck to give coupons out initially for the medication before insurance companies start covering it.
If you do have house dust mite allergies that are not well controlled with environmental control measures, speak to your allergy doctor to see if Odactra, allergy shots or taking medications is right for you.
Update 12/26/2017: Odactra is to be released January 8, 2018 and it will be manufactured by ALK. The cost of Odactra will be $291.35 a month. ALK will have a copay assistance card that will reduce the copay for cash paying patients by 100 dollars, so the cost will be $191.35. For patients with insurance the copay monthly cost will be $25 per month if approved.
Odactra will consist of 30 micrograms of house dust mite and it is approved for allergic rhinitis, with or without conjunctivitis. Studies from ALK showed that after week 8, nasal symptoms improved 20% and after 24 weeks, 48.6%.
Side effects seen usually occurred within the first 28 days after initiation of treatment, and they usually resolved within an hour. The most common side effects seen in descending order were:
- throat irritation/tickle (67%)
- itching in the mouth
- itching in the ear
- swelling of the uvula/back of mouth
- swelling of the lips
- swelling of the tongue
- tongue pain
- throat swelling
- tongue ulcer/sore on tongue
- stomach pain
- mouth ulcer/sore in the mouth
- taste alteration/food tastes different
- vomiting (2.5 %)
Patients using Odactra used injectable epinephrine 0.4% of the time compared to 0.2% for placebo.
It seems from the studies, that most people taking Odactra will experience some type of side effect, but the adverse events will be brief (30-60 minutes), and occur early (first 1-7 days) and limited in recurrence (resolution within 2 weeks). It is important for the first dose to be administered under the supervision of a doctor.
Practice guidelines recommend that patients receiving immunotherapy be treated for 3-5 years to obtain maximum benefits.