美国食品药品管理局FDA于2014年4月10日批准ORALAIR(混合花粉变应原提取物)舌下用于治疗过敏性鼻炎，这是美国批准的首个过敏原提取物舌下制剂。
Oralair的适应症是用于某些草花粉引起的伴有或不伴有眼部炎症的10~65岁过敏性鼻炎患者的治疗。生产商申请该药物用于年龄≥5岁的患者。
该药物含有5种草的冷冻干燥提取物：肯塔基蓝草、鸭茅、多年生黑麦草、甜春季草和梯牧草。
美国过敏、哮喘和免疫学会前任主席、佛罗里达州劳德代尔堡执业过敏症专科医生Linda Cox医生称，舌下片治疗将为美国每年约3,000万过敏性鼻炎受累患者提供治疗选择。Oralair每日一次，草花粉季节来临前4个月开始服用并持续整个季节。首次服药在医生诊室，后续可在家中自行服用。制造商格里尔实验室(Greer Laboratories)声称，Oralair可减少患者首个服药过敏季节草花粉导致的过敏症状。
她认为这是一个颠覆过敏性鼻炎治疗格局的产品。 “舌下免疫疗法提供了一种家庭治疗和更易获得的治疗手段，因为其安全性非常好。这可能使得该药物可用于大约90%的没有服用其他药物而仅仅是为治疗症状的患者。”
她还指出，Oralair对过敏性鼻炎标本兼治。“这将适用于正在遭受过敏季节痛苦以及使用各种产品没有达到最佳控制的人群，使他们有可能彻底摆脱疾病痛苦。”
Oralair批准令是基于在美国和欧洲纳入2,500多例成人和儿童患者的双盲安慰剂对照试验结果。为评估该药物的有效性，患者报告其症状和为控制过敏症状需要服用其他药物的情况。在一个草花粉季节治疗期间，与服用安慰剂患者相比， Oralair服用者症状和需要其他药物治疗减少16~30%。
试验表明，过敏季节前和过敏季节期间服用Oralair可减少患者过敏症状以及对症状缓解药物的需求。
据格里尔公司4月1日的声明，Oralair最常见不良事件为口腔瘙痒、咽喉刺激、耳部瘙痒、口部水肿、舌部瘙痒、咳嗽以及口咽部疼痛，发生率均小于5%。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR.
ORALAIR(Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)
Tablet for Sublingual Use
Initial U.S. Approval: 2014
WARNING: SEVERE ALLERGIC REACTIONSSee full prescribing information for complete boxed warning
ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema. (5.1)
Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma. (4)
Observe patients in the office for at least 30 minutes following the initial dose. (5.1)
Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. (5.2)
ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.2)
ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)
RECENT MAJOR CHANGES
Contraindications (4) 10/2014
Warnings and Precautions, Eosinophilic Esophagitis (5.3) 10/2014
INDICATIONS AND USAGE
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. 
DOSAGE AND ADMINISTRATION
For sublingual use only.
Age
(years) Dose
Day 1 Day 2 Day 3 and following
10-17 100 IR 2× 100 IR 300 IR
18-65 300 IR 300 IR 300 IR
Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season. (2.2)
Place the tablet under the tongue for at least 1 minute, until complete dissolution and then swallow. (2.2)
Administer the first dose of ORALAIR under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. Observe the patient for at least 30 minutes. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets, 100 IR and 300 IR (3)
CONTRAINDI