Sublingual tablet to treat dust mite allergy approved
Officials with the US FDA today approved Merck, Sharp & Dohme Corporation's Odactra, the first allergen tablet to be administered sublingually to treat house dust mite-induced nasal inflammation (allergic rhinitis), with or without eye inflammation, in adults aged 18 through 65.
In a press release, the administration noted that Odactra is a once-daily tablet that exposes patients to house dust mite allergens, gradually desensitizing the immune system to reduce the frequency and severity of nasal and eye allergy symptoms. The first dose is taken under the supervision of a health care professional with experience in the diagnosis and treatment of allergic diseases. The patient is to be observed for at least a half hour for potential adverse reactions. Provided the first dose is well tolerated, patients can then take Odactra at home. It can take about 8 to 14 weeks of daily dosing after initiation of Odactra for the patient to begin to experience a noticeable benefit.
The safety and efficacy of Odactra was evaluated in studies conducted in the United States, Canada and Europe, involving approximately 2,500 people. Some participants received Odactra, while others received a placebo pill. Participants reported their symptoms and the need to use symptom-relieving allergy medications. During treatment, participants taking Odactra experienced a 16% to 18% reduction in symptoms and the need for additional medications compared to those who received a placebo.
The most commonly reported adverse reactions were nausea, itching in the ears and mouth, and swelling of the lips and tongue. The prescribing information includes a boxed warning that severe allergic reactions, some of which can be life-threatening, can occur. As with other FDA-approved allergen extracts administered sublingually, patients receiving Odactra should be prescribed auto-injectable epinephrine.
This new treatment may be beneficial for patients with an allergy to dust mite, especially if dust mite is the only thing to
which they are allergic or if dust mite is their primary source of allergy. However, Odactra may not be the best option for many patients, as it treats only one allergen. Many patients have multiple environmental allergies and would benefit more from an allergy immunotherapy treatment tailored to their specific allergies. For example, if you are allergic to dust mite, cat and oak tree pollen and grass pollen; Odactra could help you become less allergic to dust mite but would have no effect on your allergy to pollen or cat. To treat the grass pollen, you would have to take a second tablet and at this time, there are no sublingual tablets available for tree pollen or cat. In contrast, if you are treated with immunotherapy tailored to your specific allergies, you can easily be treated for dust mite, cat (and dog if necessary) and almost all of the major pollens which cause allergic problems for allergy sufferers. This customized treatment can be administered either by injection (known as allergy shots) or sublingually (known as allergy drops). Hundreds of medical studies have shown that both of these methods of administration are very effective for many patients. However, each form of allergy treatment has its distinct advantages and disadvantages, which require careful consideration.
Although the benefits of both injection and sublingual immunotherapy can vary significantly from patient to patient, immunotherapy is a known and accepted treatment and more importantly, has proven to be effective in the long term management of allergic rhinitis and other allergic conditions. The vast majority of patients who choose this treatment notice a significant improvement in their health with a marked decrease in both allergy symptoms and a corresponding decrease in their need for medication to treat those symptoms. In addition, both injection immunotherapy (allergy shots) and aqueous sublingual immunotherapy (allergy drops) have been proven to halt the “allergic march” and reduce the chance that patients who suffer from upper respiratory allergies (hayfever, sinus problems, etc.) will develop bronchial asthma.
If you have questions about your best option to treat your allergies, including whether you are a good candidate for the new dust mite sublingual tablet, or one of the other forms of allergy immunotherapy available, please make an appointment to meet with one of our health care providers so we can carefully evaluate your specific circumstances, including your allergic status, and help you choose the treatment option which is best for you.