Delving into the Latest Updates on Azelastine Hydrochloride/Fluticasone Propionate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Azelastine/fluticasone propionate, Duonase, Dymista

+ [14]

Target

GR x H1 receptor x cPLA2α

Action

agonists, antagonists

Mechanism

GR agonists(Glucocorticoid receptor agonists), H1 receptor antagonists(Histamine H1 receptor antagonists), cPLA2α agonists(Cytosolic phospholipase A2 agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Rhinitis, AllergicRhinoconjunctivitisRhinitis, Allergic, Seasonal

Inactive Indication-

Originator Organization

Mylan NV

Active Organization

Meda ABViatris Pty Ltd.

Mylan Specialty LP

+ [2]

Inactive Organization

Meda Pharma GmbH & Co. KG

Cipla Ltd.

Meda Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (01 May 2012),

Rhinitis, Allergic, Seasonal

Regulation-

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Structure/Sequence

Molecular FormulaC25H31F3O5S

InChIKeyWMWTYOKRWGGJOA-CENSZEJFSA-N

CAS Registry80474-14-2

View All Structures (2)

Available since the 1940s, H₁ antihistamines are mainstay treatments for allergic conditions such as allergic rhinitis and urticaria. They function as inverse agonists that bind to the H₁ receptor to inhibit histamine-induced inflammation. The older, first-generation drugs are no longer recommended for patient use because of their well-documented negative adverse effect profile. Evidence has been accumulating to support a newer generation of H₁ antihistamines in oral and intranasal formulations, including in combination with intranasal corticosteroids. The literature is replete with large meta-analyses and systematic reviews establishing the safety and efficacy of second-generation H₁ antihistamines in adult and pediatric allergic rhinitis populations, including combination nasal spray agents (eg, MP29-02 or MP-AzeFlu). Although intraclass differences do exist, patient preference, access, and costs should be the priority. Robust data on the regular, not as needed use of H₁ antihistamines for urticaria have been published, including in the management of children and pregnant or lactating women. In addition, H₁ antihistamines can be used in other related allergic conditions, such as the secondary symptoms of anaphylaxis, to provide patients with greater comfort, including in allergic asthma, depending on the individual.

01 Sep 2023·Pulmonary therapy

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis

Article

Author: Cheng, Lei ; Lin, Peng ; Zhou, Huifang ; Ramalingam, Rajesh Kumar ; Fang, Hongyan ; Tan, Guolin ; Wang, Huizhong ; Nguyen, Duc Tung ; Jin, Yongde ; Zhao, Changqing ; Zhang, Hua ; Zhou, Bing ; Dong, Yaowu ; Kuhl, Hans Christian ; Pan, Jing

INTRODUCTION:

The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR).

METHODS:

We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients.

RESULTS:

MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: - 1.96; 95% CI: - 2.53, - 1.39; p < 0.0001), or the FLU group (LS mean difference: - 0.98; 95% CI: - 1.55, - 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups.

CONCLUSIONS:

MP-AzeFlu, when administered as one spray per nostril twice daily for 14 days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR.

TRIAL REGISTRATION:

Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .

12

News (Medical) associated with Azelastine Hydrochloride/Fluticasone Propionate

23 Mar 2026

·www.sandoz.com

Sandoz launches azelastine/fluticasone nasal spray in Germany and Switzerland, expanding patient access to high-quality allergy treatment option

Sandoz, the global leader in affordable medicines, announces the launch of its azelastine and fluticasone fixed-dose-combination (FDC) nasal spray in Germany and Switzerland, offering patients in both markets a high-quality allergy treatment option. Christophe Delenta, President Europe, Sandoz, says: “Seasonal allergies can have a real impact on patients, affecting sleep, concentration, productivity and overall quality of life. With the launch of our azelastine/fluticasone combination spray, Sandoz is expanding access for German and Swiss patients ahead of the 2026 allergy season, while also strengthening our position in allergy care.” In Germany, azelastine and fluticasone over-the-counter (OTC) nasal spray is used for the relief of symptoms in moderate to severe seasonal allergic rhinitis in adults1. In Switzerland, it is approved for seasonal allergic rhinitis and rhino conjunctivitis in patients aged six years and older, as well as moderate to severe perennial allergic rhinitis and rhino conjunctivitis in patients aged 12 years and older2. Between 15 and 20% of the Swiss population is affected by allergic rhinitis, corresponding to around two million people, while in Germany, up to 15 million people are impacted3. The launch of the azelastine and fluticasone FDC nasal spray will provide these patients with a high-quality alternative to the reference medicine, Dymista®*. Leveraging the established Lorano® brand, the launch in Germany is introducing an innovative FDC antihistaminic nasal spray in the OTC allergy segment, reinforcing Hexal’s leading position in OTC allergy care and its overall market-leading position. In Switzerland, it strengthens the comprehensive Sandoz antihistaminic portfolio, adding another high-potential nasal spray to the portfolio, and strategically expands the Sandoz offering in this important therapeutic area. Overall, the launch also represents an early step towards capturing the USD~340 billion generics loss of exclusivity opportunity over the next 10 years4. *Dymista® is a registered trademark of Viatris REFERENCES 1 Following the initial diagnosis by a physician and when monotherapy with either an intranasal antihistamine or a glucocorticoid is not considered sufficient. Gebrauchsinformation: Information für Patienten. Available at: Lorano® Azelastin/Fluticason Allergiespray bei Heuschnupfe [Last accessed, March 2026] 2 Summary of product characteristics. Available at: Azelastin Fluticason Sandoz® Nasenspray, Suspension. [Last accessed, March 2026] 3 Savouré M, Bousquet J, Jaakkola JJK, Jaakkola MS, Jacquemin B, Nadif R. Worldwide prevalence of rhinitis in adults: A review of definitions and temporal evolution. Clin Transl Allergy. 2022 Mar;12(3):e12130. doi:10.1002/clt2.12130. PMID: 35344304; PMCID: PMC8967272 4 Data on file. Covers US and EU markets (2026–2035). Originator sales and LoE based on internal analysis of data from multiple subscription databases. Generics data accessed in June 2025

Drug Approval

09 Aug 2024

·pharma.economictimes.indiatimes.com

Viagra-maker Viatris beats Q2 estimates on branded and generic drug demand

London: Drugmaker Viatris beat second-quarter profit and revenue estimates on Thursday, driven by strong demand for the Viagra-maker's off-patent branded and generic drugs. Shares of the company were up 3.6 per cent in premarket trade. The Canonsburg, Pennsylvania-based company also raised the 2024 sales outlook for its new product range, including Breyna - a biosimilar to Astrazeneca's asthma drug Symbicort - to between $500 million and $600 million, up from its previous range of $450 million to $550 million. Viatris, formed by the merger of Mylan and Pfizer's Upjohn business, boasts a portfolio of well-known generic branded drugs, such as erectile dysfunction drug Viagra, anti-anxiety medication Xanax, epilepsy treatment Lyrica, and arthritis treatment Celebrex. Last year, Viatris said it will divest from its over-the-counter (OTC) drugs, active pharmaceutical ingredients and women's health businesses as it wanted streamline focus on three core therapeutic areas - ophthalmology, gastroenterology and dermatology. However, the company has retained the rights to Viagra, nasal spray Dymista , and select OTC products in certain markets. Due to the OTC divestiture, it now expects 2024 revenue of $14.6 billion to $15.1 billion versus its previous forecast of $14.98 billion to $15.48 billion. The company also lowered its annual profit forecast to the range of $2.58 to $2.73 per share, down 7 cents at mid-point. Viatris' second-quarter revenue of $3.80 billion beat Wall Street estimates of $3.78 billion. Revenue from both its branded and generic drug units, excluding sales from divested businesses, increased by 2 per cent . On an adjusted basis, the company posted a profit of 69 cents per share, narrowly beating estimates of 68 cents per share. (Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid)

Acquisition

04 Jul 2024

·www.pharmaceutical-technology.com

Viatris closes $3.37bn divestitures with OTC deal

Viatris completed the last of its $3.37bn divestitures, signing a deal with Cooper Consumer Health to transfer of its OTC business. Credit: SOPA Images via Getty Images. Viatris announced the finalisation of a transaction to divest its over-the-counter (OTC) business, completing the last step in its previously declared $3.37bn divestitures. The US-headquartered company divested its entire OTC business to Cooper Consumer Health, a European OTC drug manufacturer, on 3 July. In the agreement, Cooper Consumer Health has gained access to two manufacturing plants based in Merignac, France; and Confienza, Italy, and a research and development site in Monza, Italy. In its strategic plan, Viatris retained the rights for its blockbuster generic drugs Viagra (sildenafil) and Dymista (azelastine hydrochloride and fluticasone propionate) alongside certain other OTC therapies. Viatris first spread word of the OTC divestiture in October 2023 declaring definitive agreements to divest other areas of the company. Over the last few months, the nutraceutical company Matrix Pharma Private gained access to Viatris’ active pharmaceutical ingredients division and Spanish pharmaceutical company Insud Pharma acquired Viatris’ women’s health business. The latter deal gave Insud Pharma two manufacturing plants in India. Furthermore, a December 2023 definitive agreement transferred Viatris’ European rights for therapies such as Duphaston (Dydrogesterone) and Femoston (estradiol) to Theramex . The generics company also divested commercialisation rights in some non-core markets that were acquired, when Viatris was formed through the combination of Mylan and UpJohn. As per a 3 July press release, Viatris made the various divestitures to help achieve its “long-term gross leverage target” and “increase shareholder return through share buybacks and dividends”. The generics company also plans to use the money to acquire, develop and commercialise more therapies in the future. Last year, the company generated a total revenue of $15.4bn, reaching a free cash flow of $2.4bn. By 28 January 2024, the company had already completed $250m in share repurchases for this year. See Also: Left in limbo: When pharma halts rare disease research The pathway to preventative health: How pharma can support the NHS Long Term Plan In November 2022, Viatris released a strategic update detailing a two-stage plan for business growth with plans to end Phase I by the end of this year and execute Phase II between 2024 and 2028. In the first phase, the company aimed to complete all planned divestitures, have seven consecutive quarters of strong performance and continue progress on key science programmes among other things. At the January 2024 JP Morgan Healthcare Conference, Viatris announced that it had achieved its goals for Phase I and will be advancing to Phase II, which prioritises the growth of the company’s ophthalmology division and prevention of base business erosion.

AcquisitionPhase 2

100 Deals associated with Azelastine Hydrochloride/Fluticasone Propionate

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic	Australia	Viatris Pty Ltd.	14 Jan 2014
Rhinoconjunctivitis	Switzerland	Meda AB	06 May 2013
Rhinitis, Allergic, Seasonal	United States	Mylan Specialty LP	01 May 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20190189 (Literature) Manual	Phase 3	Rhinitis, Allergic	679	AzeFlu	bbrvdwnryo(gmftslgavk) = lkrikfupup wabhwthkwt (qgkydzambr, 2.59) View more	Positive	29 Oct 2024
				MP-AzeFlu	bbrvdwnryo(gmftslgavk) = ntafbqfyve wabhwthkwt (qgkydzambr, 2.76) View more
NCT02402465 (CTgov)	Phase 4	Rhinitis, Allergic, Seasonal	22	Placebo (Placebo)	giidzfmfot(rbvkeyzydh) = ohbdvwvsjj tszeaxweoi (sthokwimqy, 53.03) View more	-	17 Oct 2024
				Nasal Allergen Challenge+Fluticasone propionate (Fluticasone Propionate)	giidzfmfot(rbvkeyzydh) = gvbpuegffg tszeaxweoi (sthokwimqy, 54.22) View more
NCT03599791 (Pubmed \| Pulm Ther)	Phase 3	Rhinitis, Allergic	900	MP-AzeFlu nasal spray	dztddakcgd(uckennrsau): P-Value = 0.0007 View more	-	01 Sep 2023
				Fluticasone propionate nasal spray
NCT01794741 (CTgov)	Phase 3	Rhinitis, Allergic	405	Dymista Nasal Spray (Dymista Nasal Spray)	fdiskvnsrl = xplbsyecjt paikrvolav (jcpbowlknu, xnkhszdzwt - uufklqmgew) View more	-	31 Mar 2015
				Fluticasone propionate nasal spray (Fluticasone Propionate Nasal Spray)	qmlslzxoul(xkyzgrzwck) = gwlzxoirwx cvxpeiwlqq (ypdhkjpkir, wgcgpygxdk - ywfwbtzhtc) View more
NCT00651118 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	832	fluticasone propionate (Fluticasone Propionate)	frhkvqoiod(zakolqeyox) = jltzpzcwnc scesgtfgnj (pcjurzvbtl, 4.7) View more	-	26 Sep 2012
				azelastine Hcl (Azelastine HCl)	frhkvqoiod(zakolqeyox) = rrypmooosm scesgtfgnj (pcjurzvbtl, 4.6) View more
NCT00740792 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	776	azelastine Hcl (Azelastine HCL)	lxlvoaswdp(bxdyntezkh) = frayxkpprc tumwljfnkk (jfcvhfxewt, 4.6) View more	-	07 Sep 2012
				fluticasone propionate (Fluticasone Propionate)	lxlvoaswdp(bxdyntezkh) = dltaqkkytk tumwljfnkk (jfcvhfxewt, 5.1) View more
NCT00883168 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	1,791	azelastineHcl (Azelastine Hcl)	yvlvbvmqsd(nxkyqnutxc) = utzwlofggp bmophqszzv (fkunxdscao, 4.8) View more	-	07 Sep 2012
				fluticasone propionate (Fluticasone Propionate)	yvlvbvmqsd(nxkyqnutxc) = rtjedlwrgb bmophqszzv (fkunxdscao, 4.7) View more
NCT00660517 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	607	azelastine Hcl (Azelastine Hcl 548 Mcg)	hqjopeosfy(jueypcsmfs) = phxpwitehx lfyatwgykx (ulernrtqio, 4.2) View more	-	23 Jul 2012
				fluticasone propionate (Fluticasone Propionate 200 Mcg)	hqjopeosfy(jueypcsmfs) = azurjswuwr lfyatwgykx (ulernrtqio, 4.8) View more