The FDA has approved Sinuva (Intersect ENT), a sinus implant that gradually releases the corticosteroid mometasone furoate over a 90-day period, for treatment of nasal polyps in adults who have had ethmoid sinus surgery. Propel, a sinus implant that releases mometasone furoate over 30 days, is FDA-approved to maintain the sinus opening after ethmoid sinus surgery; it is marketed by the same manufacturer as Sinuva.

The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.

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).

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

Montelukast (Singulair - Merck) is an oral cysteinyl leukotriene D₄ receptor antagonist originally marketed for treatment of asthma. It was approved by the FDA in 2003 for treatment of seasonal allergic rhinitis and recently for use in perennial allergic rhinitis in adults and children ≥ 6 months old. Intranasal corticosteroids have generally been considered the most effective drugs available for prevention and treatment of allergic rhinitis.

Esketamine (Spravato – Janssen), an intranasal N-methyl-D-aspartate (NMDA) receptor antagonist that was previously approved by the FDA for treatmentresistant depression,1 has now been approved for treatment of depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior. Esketamine is the S-enantiomer of the anesthetic ketamine (Ketalar, and generics). It is the first drug to be approved for this indication. Most clinical trials of antidepressants have excluded patients with acute suicidal ideation.

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,...

The FDA has approved esketamine (Spravato – Janssen), an N-methyl-D-aspartate (NMDA) receptor antagonist, for intranasal treatment (in conjunction with an oral antidepressant) of adults with treatment-resistant depression (TRD). This is the first FDA approval for esketamine, which is the S-enantiomer of the intravenous anesthetic ketamine (Ketalar, and generics). In recent years, IV ketamine has been increasingly used (off-label) for treatment of TRD.

The FDA is requiring stronger warnings in the labeling of the leukotriene receptor antagonist montelukast (Singulair, and generics) about the risk of suicidal behavior and other serious neuropsychiatric events associated with its use.

Tyrvaya (Oyster Point), a nasal spray formulation of the cholinergic agonist varenicline, has been approved by the FDA for treatment of dry eye disease. It is the first nasal spray to be approved in the US for this indication. An oral formulation of varenicline (Chantix, and generics) has been available for years for smoking cessation.