GREER Laboratories launches Oralair to treat grass pollen allergy

ORALAIR is an allergen extract 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 the first and only FDA approved oral allergy immunotherapy tablet that includes a five grass, mixed pollens allergen extract. These grasses are widely distributed throughout the US.

GREER president and CEO John G Roby noted that the company is pleased to now be able to supply ORALAIR which provides an additional option for treating grass allergies in the US and helps to fill a current unmet need in allergy patient care.

"Grass allergies affect millions of people, however we know that many patients who are candidates for immunotherapy refuse or discontinue allergy injections. GREER’s commitment to allergy innovation is guided by our desire to provide support to allergy specialists and relief to patients through immunotherapy," Roby added.

ORALAIR is taken for about four months before the expected start of the grass pollen season and is continued throughout the grass pollen season. ORALAIR is a tablet that dissolves under the tongue. The first dose is taken in the allergy specialist’s office under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions.

The patient will be observed for at least 30 minutes for symptoms of serious allergic reactions. If the patient tolerates the first dose, the remaining doses are administered once a day by the patient or the patient’s caregiver.

ORALAIR reduces grass allergy symptoms for patients within the first allergy season that it is taken. ORALAIR is not indicated for the immediate relief of allergy symptoms. The prescribing information for ORALAIR includes a Boxed Warning regarding severe allergic reactions.

ORALAIR also provides significant symptom relief for the long term. In a five-year, multicenter clinical trial of 426 adults in 10 European countries, efficacy was sustained during three years of treatment and ORALAIR significantly reduced daily Combined Score (CS) compared with placebo during every year of treatment. Data were insufficient to demonstrate efficacy for one or two years after discontinuation of ORALAIR.

The ORALAIR clinical program was based on safety, efficacy and tolerability results from an extensive set of clinical trials which included, in both the US and Europe, over 2,500 adults and children. ORALAIR was generally well tolerated and the most common adverse events (reported in =5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough and oropharyngeal pain.

GREER holds exclusive US commercialization rights to ORALAIR through its partnership with STALLERGENES, developer and manufacturer of the product.