Chemistry:Roflumilast

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Roflumilast, sold under the brand name Daxas among others, is a medication used for the treatment of chronic obstructive pulmonary disease,[1] plaque psoriasis,[2] seborrheic dermatitis,[3] and atopic dermatitis.[2] It acts as a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE-4).[4] It has anti-inflammatory effects.[4][5][6]

It was approved for medical use in the European Union in 2010,[7] in the United States in 2011,[1] and in Canada in 2017.[8] It is available as a generic medication.[9]

Medical uses

Roflumilast is indicated for the treatment of severe chronic obstructive pulmonary disease (COPD),[1] plaque psoriasis,[2][10] seborrheic dermatitis,[3] and atopic dermatitis,[2][11]

It is used in the prevention of exacerbations (lung attacks) in severe chronic obstructive pulmonary disease (COPD).[12][1][7][13][14]

Adverse effects

Common (1–10% incidence) adverse effects include diarrhea, weight loss, nausea, headache, insomnia, decreased appetite, abdominal pain, rhinitis, sinusitis, urinary tract infection, and depression.[1][12][13][14][15]

Society and culture

In June 2010, it was approved in the European Union for severe COPD associated with chronic bronchitis.[7][16] In February 2011, it gained FDA approval in the United States for reducing COPD exacerbations.[17][18]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 "Daliresp- roflumilast tablet". 12 March 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9a1d0a8-581f-4f91-a2b8-f419192d0ebf. 
  2. ↑ 2.0 2.1 2.2 2.3 "Zoryve- roflumilast cream". 16 August 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec1bb0d1-f38a-4080-831a-68791d1d1fdb. 
  3. ↑ 3.0 3.1 "Zoryve- roflumilast aerosol, foam". 20 December 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f9e0b4a9-a227-4947-b00c-41fb18d16589. 
  4. ↑ 4.0 4.1 "PDE4 inhibitors as potential therapeutic agents in the treatment of COPD-focus on roflumilast". International Journal of Chronic Obstructive Pulmonary Disease 2 (2): 121–9. 2007. PMID 18044684. 
  5. ↑ "Suppression of cytokine expression by roflumilast and dexamethasone in a model of chronic asthma". Clinical and Experimental Allergy 38 (5): 847–56. May 2008. doi:10.1111/j.1365-2222.2008.02950.x. PMID 18307529. 
  6. ↑ "Roflumilast: an oral, once-daily selective PDE-4 inhibitor for the management of COPD and asthma". Expert Opinion on Investigational Drugs 17 (5): 811–8. May 2008. doi:10.1517/13543784.17.5.811. PMID 18447606. 
  7. ↑ 7.0 7.1 7.2 "Daxas EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/daxas. 
  8. ↑ "Daxas Product information". 20 July 2017. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84447. 
  9. ↑ "2022 First Generic Drug Approvals". 3 March 2023. https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/2022-first-generic-drug-approvals. 
  10. ↑ "FDA Approves Arcutis' Zoryve (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older" (Press release). Arcutis Biotherapeutics. 29 July 2022. Archived from the original on 1 August 2022. Retrieved 1 August 2022 – via GlobeNewswire.
  11. ↑ "FDA Approves Atopic Dermatitis Label Expansion for Arcutis' Zoryve Cream". 10 July 2024. https://www.biospace.com/article/fda-approves-atopic-dermatitis-label-expansion-for-arcutis-zoryve-topical-cream-/. 
  12. ↑ 12.0 12.1 "Daxas 250 micrograms tablets - Summary of Product Characteristics (SmPC)". 11 June 2020. https://www.medicines.org.uk/emc/product/9162/smpc. 
  13. ↑ 13.0 13.1 "Daliresp : EPAR - Product Information". European Medicines Agency. Takeda GmbH. 26 September 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002398/WC500103078.pdf. 
  14. ↑ 14.0 14.1 "roflumilast (Rx) - Daliresp". Medscape Reference. WebMD. http://reference.medscape.com/drug/daliresp-roflumilast-999626. 
  15. ↑ "PDE4 inhibitors: current status". British Journal of Pharmacology 155 (3): 308–15. October 2008. doi:10.1038/bjp.2008.307. PMID 18660825. 
  16. ↑ ""Nycomed's Anti-Inflammatory Gains Approval in EU for COPD"". http://www.genengnews.com/gen-news-highlights/nycomed-s-anti-inflammatory-gains-approval-in-eu-for-copd/81243622/. 
  17. ↑ "Drug Approval Package: Daliresp Tablets (roflumilast) NDA #022522". 24 December 1999. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000TOC.cfm. 
  18. ↑ "FDA approves new drug to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration (FDA). 1 March 2011. Archived from the original on 18 January 2017. Retrieved 16 December 2019.

Further reading



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