The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.

View the Comparison Table: Some Nasal Sprays for Seasonal Allergic Rhinitis

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.

The FDA has approved the over-the-counter (OTC) sale of Nasacort Allergy 24HR (Sanofi), a triamcinolone acetonide nasal spray previously available only by prescription as Nasacort AQ. The OTC product, which is scheduled to be marketed in the spring of 2014, will be the first corticosteroid nasal spray that can be purchased without a prescription in the US. Nasacort Allergy 24HR is approved for use in patients ≥2 years old with nasal allergy symptoms.

The FDA has approved 3 allergen extracts for sublingual administration as immunotherapy for allergic rhinitis confirmed by a positive skin test or in vitro testing for pollen-specific IgE antibodies: Oralair (Stallergenes S.A./Greer) and Grastek (Merck) for grass pollen-induced allergic rhinitis and Ragwitek (Merck) for short ragweed pollen-induced allergic rhinitis.

In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.CLINICAL STUDIES — In a randomized, open-label,...

An intranasal spray formulation of the corticosteroid fluticasone propionate (floo tik a sone; Flonase - Allen & Hanburys) has been approved by the US Food and Drug Administration for treatment of seasonal and perennial allergic rhinitis in adults and children more than 12 years old.

The FDA has approved Odactra (ALK), a sublingual allergen extract, for immunotherapy in adults 18-65 years old with house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. Odactra is the first sublingual allergen extract to be approved in the US for this indication. Three other sublingual allergen extracts were approved earlier (see Table 1).

Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.