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Background: Intranasal sprays (INSs) are commonly used medications for the treatment of many rhinologic conditions. Despite their popularity, an analysis of a nationwide reporting database and comparison to the available literature has never been performed. Methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) database was accessed to obtain adverse event (AE) records from 2014 to 2019 for varying INSs, including: 10 corticosteroids, 1 alpha adrenergic, and 3 antihistamines. The Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) were calculated for dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache. A PRR ≥ 2 or ROR ≥ 1 was considered significant. Results: Corticosteroids had 98 864 total reported AEs to the database, followed by antihistamines (7011) and alpha adrenergics (2071). In total, dyspnea was reported 5843 times, followed by headache (4230), epistaxis (1205), ageusia/dysgeusia (920), and anosmia (312). Overall, PRR and ROR values for dyspnea ranged from 0.51 to 4.25 and 0.51 to 4.49; for dysgeusia/ageusia from 0.56 to 6.09 and 0.56 to 6.12; and for epistaxis from 1.03 to 27.24 and 1.03 to 30.76, respectively. All medications which listed anosmia within the top AEs had PRR and ROR values exceeding 2 and 1, respectively. The PRR for headache exceeded 2 for 1 medication and the ROR exceeded 1 in 7 medications. Conclusion: The AEs of dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache are reported within the FAERS database for commonly prescribed INSs. When compared against the existing scientific literature, the clinical significance of this reporting tool from the FDA for these classes of medications remains unvalidated. [ABSTRACT FROM AUTHOR]

Rhinitis is often the first symptom of allergy but is frequently ignored and classified as a nuisance condition. Ironically it has the greatest socioeconomic burden worldwide caused by its impact on work and on daily life. However, patients appear reticent to seek professional advice, visiting their doctor only when symptoms become 'intolerable' and often when their usual therapy proves ineffective. Clearly, it's time for new and more effective allergic rhinitis treatments. MP29-02 (Dymista®; Meda, Solna, Sweden) is a new class of medication for moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or intranasal corticosteroids is not considered sufficient. MP29-02 is a novel formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP). It benefits not only from the incorporation of two active agents, but also from a novel formulation; its lower viscosity, smaller droplet size, larger volume (137 µl) and wider spray angle ensure optimal coverage of, and retention on the nasal mucosa and contribute to its clinical efficacy. In clinical trials, patients treated with MP29-02 experienced twice the symptom relief as those treated with FP and AZE, who in turn exhibited significantly greater symptom relief than placebo-patients. Indeed, the advantage of MP29-02 over FP was approximately the same as that shown for FP over placebo. The advantage of MP29-02 was particularly evident in those patients for whom nasal congestion is predominant, with MP29-02 providing three times the nasal congestion relief of FP ( = 0.0018) and five times the relief of AZE ( = 0.0001). Moreover, patients treated with MP29-02 achieved each p p and every response up to a week faster than those treated with FP or AZE alone and in real life 1 in 2 patients reported the perception of well-controlled disease after only 3 days. MP29-02's superiority over FP was also apparent long-term in patients with perennial allergic rhinitis or non-allergic rhinitis, with statistical significance noted from the first day of treatment, with treatment difference maintained for a full year. Taken together, these data suggest that MP29-02 may improve the lives of many of our patients, enabling them to finally escape the allergic rhinitis trap. [ABSTRACT FROM AUTHOR]

Background: Intranasal sprays are recommended as targeted therapy for allergic rhinitis (AR) by providing direct delivery of medication to the nasal mucosa, reducing the potential for systemic adverse effects, decreasing burden of disease, and improving quality of life. Objective: To review currently available intranasal sprays indicated for maintenance therapy of AR in the United States: intranasal antihistamines (INAH); intranasal corticosteroids (INCS); and MP-AzeFlu, a single formulation nasal spray of the INAH, azelastine hydrochloride, and the INCS, fluticasone propionate. Methods: MEDLINE searches were conducted to identify placebo-controlled studies of commercially available prescription nasal sprays at U.S.-approved doses and indications, and published after an earlier systematic review of AR treatment. Inclusion criteria were ≥20 subjects; duration of ≥2 weeks for seasonal (or episodic) AR, ≥4 weeks for perennial (or persistent) AR, and reporting a total nasal symptom score as a primary or secondary outcome. Results: Twenty studies met the inclusion criteria: 4 pediatric, 16 adult/adolescent. There were 4 perennial AR studies (381 children, 1607 adults) and 16 seasonal AR trials (3081 children, 6548 adults). In these studies, 2451 subjects (481 children, 1970 adults) received an INCS, 3001 (1116 children, 1885 adults) received an INAH, and 346 adult subjects received MP-AzeFlu. All active treatments were well tolerated and effective as measured by the reduction in nasal symptoms. Head-to-head comparisons were only available for MP-AzeFlu versus the individual active agent components. MP-AzeFlu provided significantly greater symptom relief than either azelastine or fluticasone propionate alone and with an onset starting at 30 minutes after the dose. Conclusion: The most recent addition to intranasal sprays for the maintenance therapy of AR is MP-AzeFlu, a single formulation nasal spray of azelastine hydrochloride and fluticasone propionate in an advanced delivery system. Analysis of clinical data showed this to be the first new intranasal medication that provides greater clinical benefit than an INCS in treating AR. [ABSTRACT FROM AUTHOR]

Intranasal medication for eustachian tube dysfunction (ETD) is an established practice in otolaryngology through the effects of steroids, decongestants, antihistamines or a combination of the above in reducing tubal oedema. The author has previously argued that a double-blind, randomised control trial would be helpful in determining effectiveness of treatment, if a standardised head position, chiefly Mygind or Ragan, was adopted to maximise intranasal drop delivery into the eustachian tube orifice. One recent paper suggests that intranasal treatment is not very effective, but ultimately does not state whether a standardised head position was adopted. Although a large body of evidence supports the hypothesis that the nasal passages are the route to middle ear disease, there is as yet no paper that has been published that has specifically addressed this issue, therefore the author must conclude that evidence to support intranasal treatment for ETD is still lacking and further research is desirable. [ABSTRACT FROM AUTHOR]

Background: Allergic rhinitis (AR) is a global health problem because of its increasing impact on economics, society, and the individual's quality of life. This study compares the outcomes and cost of three intranasal therapeutic approaches to the treatment of AR. Methods: This was a retrospective cohort study using propensity scores to achieve balanced cohorts. The study population included patients ≥16 years of age with at least one intranasal prescription claim, without concurrent nasal polyps or sinusitis. Health care use and costs, airway infections, pharmacy costs, and indicators of unsatisfactory treatment (i.e., treatment augmentation or switching) were evaluated in the 1-year follow-up period using a claims database. Results: Data from 141,190 patients in intranasal antihistamines (INA) therapy, intranasal steroids (INS) therapy, and intranasal combination therapy (ICT) cohorts were analyzed. The INA cohort showed the lowest rate of change in treatment (switching or augmentation). Switching rates were lowest in the INS therapy cohort, whereas augmentation was lowest in the INA cohort. AR- and asthma-related medication costs were significantly lower in the INA cohort. No differences were observed in airway infections and overall health care costs. Concurrent chronic obstructive pulmonary disorder and asthma were the strongest predictors of health care cost and respiratory infection in the follow-up period. Conclusion: A change in treatment was noted in ∼1/3 of the entire study population. None of the treatments had a remarkable effect on health care costs or the occurrence of airway infections. The INA treatment cohort had lower AR- and asthma-related medication costs. [ABSTRACT FROM AUTHOR]