4.3 Review

Safety evaluation of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) for allergic rhinitis

Journal

EXPERT OPINION ON DRUG SAFETY
Volume 15, Issue 1, Pages 117-129

Publisher

TAYLOR & FRANCIS LTD
DOI: 10.1517/14740338.2016.1122755

Keywords

allergic rhinitis; azelastine; Dymista; fluticasone propionate; MP29-02; safety

Funding

  1. ALK-Abello
  2. Allergopharma
  3. Bionorica
  4. Dr. Pfleger
  5. Stallergenes
  6. HAL
  7. Artu Biologicals
  8. Allergy Therapeutics/Bencard
  9. Hartington
  10. Lofarma
  11. MEDA
  12. MSD
  13. Novartis/Leti
  14. ROXALL
  15. GSK
  16. Essex-Pharma
  17. Cytos
  18. Curalogic
  19. UK National Health Service
  20. British Lung Foundation
  21. Aerocrine
  22. AKL Ltd
  23. Almirall
  24. AstraZeneca
  25. Boehringer Ingelheim
  26. Chiesi
  27. Eli Lilly
  28. GlaxoSmithKline
  29. Merck
  30. Mundipharma
  31. Napp
  32. Novartis
  33. Orion
  34. Pfizer
  35. Respiratory Effectiveness Group
  36. Takeda
  37. Teva
  38. Zentiva
  39. Cipla
  40. Kyorin
  41. SkyePharma
  42. Medical Research Council
  43. Efficacy and Mechanism Evaluation programme

Ask authors/readers for more resources

Introduction: As a chronic disease, allergic rhinitis (AR) requires regular use of allergy medications for the effective management of symptoms. It is therefore imperative that AR treatments not only provide adequate symptom control but are also well tolerated.Areas covered: MP29-02 (Dymista, Meda, Solna, Sweden) is the first new class of AR medication (WHO ATC R01AD58) since the introduction of intranasal corticosteroids (INS) almost 50years ago. It is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate delivered in a single spray. Here we review all the safety information relevant to MP29-02, from the initial phase I bioavailability and disposition data, to the phase III 14-day and 52-week data and finally to phase IV safety data collected during MP29-02 use in routine clinical practice.Expert opinion: MP29-02 is the first real therapeutic advance in AR since the introduction of INS and has the potential to change the way this disease is managed, simplifying AR treatment regimens to a single puff in each nostril twice a day. Patients will benefit from superior symptom relief MP29-02 compared to INS with the added assurance that the safety of MP29-02 has been confirmed in the short term and long term as well as in real life.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.3
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

Letter Medicine, Research & Experimental

A Response to: Letter to the Editor Regarding Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab

Andrew Menzies-Gow, Flavia L. Hoyte, David B. Price, David Cohen, Peter Barker, James Kreindler, Maria Jison, Christopher L. Brooks, Peggy Papeleu, Rohit Katial

ADVANCES IN THERAPY (2022)

Article Respiratory System

Asthma exacerbations are associated with a decline in lung function: a longitudinal population-based study

Seyi Soremekun, Liam G. Heaney, Derek Skinner, Lakmini Bulathsinhala, Victoria Carter, Isha Chaudhry, Naeimeh Hosseini, Neva Eleangovan, Ruth Murray, Trung N. Tran, Benjamin Emmanuel, Esther Garcia Gil, Andrew Menzies-Gow, Matthew Peters, Njira Lugogo, Rupert Jones, David B. Price

Summary: This study, based on a large nationwide cohort of asthma patients, found that asthma exacerbations are associated with faster decline in lung function, especially in younger patients.

THORAX (2023)

Article Computer Science, Information Systems

Defining clinical subtypes of adult asthma using electronic health records: Analysis of a large UK primary care database with external validation

Elsie M. F. Horne, Susannah McLean, Mohammad A. Alsallakh, Gwyneth A. Davies, David B. Price, Aziz Sheikh, Athanasios Tsanas

Summary: This study defined and validated asthma subtypes using large longitudinal primary care electronic health records (EHRs). The results showed that asthma subtypes were primarily defined by the level of steroid use, level of healthcare utilization, and the presence of comorbidities. This has important clinical implications for defining asthma subtypes, facilitating patient stratification, and developing more personalized monitoring and treatment strategies.

INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS (2023)

Article Respiratory System

Observational UK cohort study to describe intermittent oral corticosteroid prescribing patterns and their association with adverse outcomes in asthma

Heath Heatley, Trung N. Tran, Arnaud Bourdin, Andrew Menzies-Gow, David Joshua Jackson, Ekaterina Maslova, Jatin Chapaneri, Derek Skinner, Victoria Carter, Jeffrey Shi Kai Chan, Con Ariti, John Haughney, David B. Price

Summary: Intermittent oral corticosteroid (OCS) use for asthma is associated with increased risks of adverse outcomes. More frequent prescribing patterns of OCS are associated with higher risks of adverse outcomes, particularly pneumonia and sleep apnea. Mitigation strategies are needed to minimize intermittent OCS prescription in primary care.

THORAX (2022)

Article Allergy

Effect of Stepping Up to High-Dose Inhaled Corticosteroids in Patients With Asthma: UK Database Study

Ian D. Pavord, Trung N. Tran, Rupert C. Jones, Javier Nuevo, Maarten van den Berge, Guy G. Brusselle, Andrew N. Menzies-Gow, Derek Skinner, Victoria Carter, Janwillem W. H. Kocks, David B. Price

Summary: A historic cohort study was conducted to determine the effectiveness of stepping up to high-dose inhaled corticosteroids (ICSs) in patients with asthma. The study found no evidence that increasing the dose to high-dose ICSs is effective in preventing future asthma exacerbations.

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE (2023)

Article Allergy

Comparative effectiveness of Anti-IL5 and Anti-IgE biologic classes in patients with severe asthma eligible for both

Paul E. Pfeffer, Nasloon Ali, Ruth Murray, Charlotte Ulrik., Trung N. Tran, Jorge Maspero, Matthew Peters, George C. Christoff, Mohsen Sadatsafavi, Carlos A. Torres-Duque, Alan Altraja, Lauri Lehtimaki, Nikolaos G. Papadopoulos, Sundeep Salvi, Richard W. Costello, Breda Cushen, Enrico Heffler, Takashi Iwanaga, Mona Al-Ahmad, Desiree Larenas-Linnemann, Piotr Kuna, Joao A. Fonseca, Riyad Al-Lehebi, Chin Kook Rhee, Luis Perez-de-Llano, Diahn-Warng Perng Steve, Bassam Mahboub, Eileen Wang, Celine Goh, Juntao Lyu, Anthony Newell, Marianna Alacqua, Andrey S. Belevskiy, Mohit Bhutani, Leif Bjermer, Unnur Bjornsdottir, Arnaud Bourdin, Anna von Boulow, John Busby, Giorgio Walter Canonica, Borja G. Cosio, Delbert R. Dorscheid, Mariana Munoz-Esquerre, J. Mark FitzGerald, Esther Garcia Gil, Peter G. Gibson, Liam G. Heaney, Mark Hew, Ole Hilberg, Flavia Hoyte, David J. Jackson, Mariko Siyue Koh, Hsin-Kuo Bruce Ko, Jae Ha Lee, Sverre Lehmann, Claudia Chaves Loureiro, Dora Ludviksdottir, Andrew N. Menzies-Gow, Patrick Mitchell, Andriana I. Papaioannou, Todor A. Popov, Celeste M. Porsbjerg, Laila Salameh, Concetta Sirena, Camille Taille, Christian Taube, Yuji Tohda, Michael E. Wechsler, David B. Price

Summary: This study aimed to describe the profile of severe asthma patients eligible for both anti-IgE and anti-IL5/5R and compare the effectiveness of these two treatments in real-life settings. The results showed that anti-IL5/5R was superior to anti-IgE in reducing asthma exacerbations and long-term oral corticosteroid use, while there was some evidence suggesting a decrease in asthma-related hospitalizations with anti-IL5/5R treatment.

ALLERGY (2023)

Article Developmental Biology

16p11.2 deletion accelerates subpallial maturation and increases variability in human iPSC-derived ventral telencephalic organoids

Rana Fetit, Michela Ilaria Barbato, Thomas Theil, Thomas Pratt, David J. Price

Summary: Inhibitory interneurons play a key role in regulating cortical circuit activity and their dysfunction is associated with autism spectrum disorder (ASD). This study investigates the effects of a genetic microdeletion, 16p11.2, which is linked to ASD, on the development of interneurons. Using human induced pluripotent stem cells, the researchers found that the microdeletion leads to increased variability in organoid size, neural rosette area, and expression of specific markers. The microdeletion also lengthens the cell cycle of ventral progenitors, promoting premature differentiation into interneurons.

DEVELOPMENT (2023)

Article Medicine, General & Internal

Individualised risk prediction model for exacerbations in patients with severe asthma: protocol for a multicentre real-world risk modelling study

Tae Yoon Lee, Mohsen Sadatsafavi, Chandra Prakash Yadav, David B. Price, Richard Beasley, Christer Janson, Mariko Siyue Koh, Rupsa Roy, Wenjia Chen

Summary: This study aims to develop and validate a novel risk prediction model for severe exacerbations in patients with severe asthma, and to examine the potential clinical utility of this tool.

BMJ OPEN (2023)

Article Primary Health Care

Implementation of a primary care asthma management quality improvement programme across 68 general practice sites

Francis J. Gilchrist, William D. Carroll, Sadie Clayton, David Price, Ian Jarrold, Iain Small, Emma J. Sutton, Warren Lenney

Summary: Despite guidelines, asthma is frequently misdiagnosed and control is poor. Large scale management programmes can improve outcomes. This study developed a primary care asthma management quality improvement programme and found modest but statistically significant improvements in asthma outcomes.

NPJ PRIMARY CARE RESPIRATORY MEDICINE (2023)

Article Allergy

Cluster Analyses From the Real-World NOVELTY Study: Six Clusters Across the Asthma-COPD Spectrum

Rod Hughes, Eleni Rapsomaniki, Aruna T. Bansal, Jorgen Vestbo, David Price, Alvar Agusti, Richard Beasley, Malin Fageras, Marianna Alacqua, Alberto Papi, Hana Mullerova, Helen K. Reddel

Summary: Cluster analysis in patients with asthma and/or COPD identified distinct clusters with characteristics that differed from conventional diagnostic features. The overlap between clusters suggests that they do not reflect discrete underlying mechanisms.

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE (2023)

Article Medicine, Research & Experimental

Greenhouse Gas Emissions from Respiratory Treatments: Results from the SABA CARBON International Study

Ashraf Alzaabi, John P. Bell, Felicia Montero-Arias, David B. Price, David J. Jackson, Hao-Chien Wang, Nigel Budgen, Hisham Farouk, Ekaterina Maslova

Summary: This study retrospectively quantified the carbon footprint of short-acting beta 2-agonist (SABA) and controller inhalers in respiratory care, and found that SABA overuse is the main contributor to the carbon footprint of respiratory treatment. This is important for healthcare systems to reduce carbon emissions and improve patient outcomes.

ADVANCES IN THERAPY (2023)

Editorial Material Allergy

Next generation health guidelines: The role of real-life data in evidence-based medicine

G. Walter Canonica, Ioana Agache, Holger J. Schunemann, Nicolas Roche, David Price, Stefano del Giacco

ALLERGY (2023)

Article Respiratory System

Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

Christian Domingo, Klaus F. Rabe, David Price, Guy Brusselle, Michael E. Wechsler, Changming Xia, Nami Pandit-Abid, Rebecca Gall, Paul J. Rowe, Yamo Deniz, Juby A. Jacob-Nara, Amr Radwan

Summary: This post hoc analysis evaluates the long-term effects of dupilumab on severe OCS-dependent asthma, and finds that it improves clinical outcomes and reduces OCS dose irrespective of baseline disease severity.

ERJ OPEN RESEARCH (2023)

Article Allergy

Clinician views on how clinical decision support systems can help diagnose asthma in primary care: a qualitative study

Luke Daines, Eddie Donaghy, Anne Canny, Victoria Murray, Leo Campbell, Carol Stonham, Andrew Bush, Brian Mckinstry, Heather Milne, David Price, Aziz Sheikh, Hilary Pinnock

Summary: ObjectiveAsthma diagnosis can be challenging in primary care. This study aimed to explore health professionals' perspectives on the value of a clinical decision support system (CDSS) for asthma diagnosis and the barriers and facilitators for its use in UK primary care. Qualitative interviews were conducted with doctors and nurses who had experience diagnosing asthma, and the findings revealed that participants recognized the potential benefits of a CDSS in structuring consultations, extracting relevant information from health records, and visually communicating findings to patients. Key factors for successful implementation included evidence-based content, regular updates, integration with existing software, and ease of use. Experienced clinicians expressed skepticism about the usefulness of a CDSS in routine practice, but believed it would be beneficial for trainees or less experienced colleagues.

JOURNAL OF ASTHMA (2023)

No Data Available