Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2014

Specific Treatments:

grass pollen-induced allergic rhinitis with or without conjunctivitis

General Information

Oralair is an allergen immunotherapy. It is a mixed allergen extract of the following five pollens: Sweet Vernal (Anthoxanthum odoratum L), Orchard (Dactylis glomerata L), Perennial Rye (Lolium perenne L), Timothy (Phleum pratense L), and Kentucky Blue Grass (Poa pratensis L).

Oralair is specifically indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. Oralair is approved for use in persons 10 through 65 years of age. Oralair is not indicated for the immediate relief of allergy symptoms.

Oralair is supplied as a sublingual tablet for oral (under the tongue) administration. For adults 18 through 65 years of age, the recommended dose is 300 IR (index of reactivity) daily. For children and adolescents 10 through 17 years of age, the dose is increased over the first three days as follows: Day 1: 100 IR, Day 2: 200 IR and Day 3: 300 IR.
The first dose of Oralair should be administered in a healthcare setting in which acute allergic reactions can be treated under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. After receiving the first dose of Oralair, the patient should be observed for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.

Clinical Results

FDA Approval
The FDA approval of Oralair was based on five trials; four natural field studies and one environmental exposure chamber study.
Natural Field Studies:
These included three trials, each conducted over a single season (two in adults and one in adolescents and children) and one five-year study (adults). Subjects received Oralair or placebo daily for four months prior to grass pollen season and throughout grass pollen season. The efficacy of Oralair was assessed via daily recording of symptoms and rescue medication use. The daily Combined Score (CS, range: 0-3) equally weights symptoms and rescue medication use. The daily Rhinoconjunctivitis Total Symptom Score (RTSS, range 0-18) is the total of the six individual symptom scores (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each graded by participants on a 0 (no symptoms) to 3 (severe symptoms) scale. The daily Rescue Medication Score (RMS, range 0-3) grades the intake of rescue medication as 0 = absent, 1 = antihistamine, 2 = nasal corticosteroid, 3 = oral corticosteroid. The primary endpoints were reached in each of the studies, with significant improvements in each of the the measurements of efficacy over placebo..
Allergen environmental chamber study
In an allergen environmental chamber study, 89 adults with grass pollen-associated allergic rhinoconjunctivitis were challenged with four of the five grass pollens contained in Oralair at baseline and after 4 months of treatment with Oralair (n=45) or placebo (n=44). The average Rhinoconjunctivitis Total Symptom Score (RTSS) of each group during the 4 hours of the allergen challenge was assessed. The primary endpoints were achieved; with significant improvements in the measurement of efficacy over placebo.

Side Effects

Adverse events associated with the use of Oralair may include, but are not limited to, the following:

  • oral pruritus
  • throat irritation
  • ear pruritus
  • mouth edema
  • tongue pruritus
  • cough
  • oropharyngeal pain

Mechanism of Action

Oralair is an allergen immunotherapy. It is a mixed allergen extract of the following five pollens: Sweet Vernal (Anthoxanthum odoratum L), Orchard (Dactylis glomerata L), Perennial Rye (Lolium perenne L), Timothy (Phleum pratense L), and Kentucky Blue Grass (Poa pratensis L).

Additional Information

For additional information regarding Oralair or grass pollen allergy, please visit the Greer Labs web page.