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Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
Tetracycline‐class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second‐generation tetracycline‐class antibiotics, including doxycycline and minocycline, may be reduced by co‐administration with food, resulting in potent...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286649/ https://www.ncbi.nlm.nih.gov/pubmed/34923732 http://dx.doi.org/10.1111/dth.15275 |
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author | Grada, Ayman Del Rosso, James Q. Graber, Emmy Bunick, Christopher G. Stein Gold, Linda Moore, Angela Y. Baldwin, Hilary Obagi, Zaidal Damiani, Giovanni Carrothers, Timothy McNamee, Brian Hanze, Eva |
author_facet | Grada, Ayman Del Rosso, James Q. Graber, Emmy Bunick, Christopher G. Stein Gold, Linda Moore, Angela Y. Baldwin, Hilary Obagi, Zaidal Damiani, Giovanni Carrothers, Timothy McNamee, Brian Hanze, Eva |
author_sort | Grada, Ayman |
collection | PubMed |
description | Tetracycline‐class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second‐generation tetracycline‐class antibiotics, including doxycycline and minocycline, may be reduced by co‐administration with food, resulting in potentially lower clinical efficacy. Development of novel compounds and formulations that are not impacted by diet could improve compliance, absorption, and effectiveness among patients. The objective of this study is to investigate weight‐based dosing protocols and the impact of food intake, including high‐fat meals, on the absorption, and clinical efficacy of sarecycline, a novel oral narrow‐spectrum third‐generation tetracycline‐class antibiotic approved by the Food and Drug Administration for acne vulgaris treatment. Data from 12 clinical studies were analyzed using population pharmacokinetic modeling, exposure–response modeling and pharmacodynamics to evaluate sarecycline dosing recommendations. The extent of exposure is estimated to decrease by 21.7% following co‐administration of a sarecycline tablet with a high‐fat meal. Based on the PopPK‐PD model, this is equivalent to a decrease in efficacy of 0.9 inflammatory lesions, which is not clinically meaningful. Sarecycline can be administered using weight‐based dosing with or without food. Co‐administration with high‐fat food has a limited impact on clinical efficacy. The pharmacokinetics of oral sarecycline may provide added convenience and support ease of use and improved compliance for acne vulgaris patients. |
format | Online Article Text |
id | pubmed-9286649 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92866492022-07-19 Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy Grada, Ayman Del Rosso, James Q. Graber, Emmy Bunick, Christopher G. Stein Gold, Linda Moore, Angela Y. Baldwin, Hilary Obagi, Zaidal Damiani, Giovanni Carrothers, Timothy McNamee, Brian Hanze, Eva Dermatol Ther Original Articles Tetracycline‐class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second‐generation tetracycline‐class antibiotics, including doxycycline and minocycline, may be reduced by co‐administration with food, resulting in potentially lower clinical efficacy. Development of novel compounds and formulations that are not impacted by diet could improve compliance, absorption, and effectiveness among patients. The objective of this study is to investigate weight‐based dosing protocols and the impact of food intake, including high‐fat meals, on the absorption, and clinical efficacy of sarecycline, a novel oral narrow‐spectrum third‐generation tetracycline‐class antibiotic approved by the Food and Drug Administration for acne vulgaris treatment. Data from 12 clinical studies were analyzed using population pharmacokinetic modeling, exposure–response modeling and pharmacodynamics to evaluate sarecycline dosing recommendations. The extent of exposure is estimated to decrease by 21.7% following co‐administration of a sarecycline tablet with a high‐fat meal. Based on the PopPK‐PD model, this is equivalent to a decrease in efficacy of 0.9 inflammatory lesions, which is not clinically meaningful. Sarecycline can be administered using weight‐based dosing with or without food. Co‐administration with high‐fat food has a limited impact on clinical efficacy. The pharmacokinetics of oral sarecycline may provide added convenience and support ease of use and improved compliance for acne vulgaris patients. John Wiley & Sons, Inc. 2021-12-30 2022-03 /pmc/articles/PMC9286649/ /pubmed/34923732 http://dx.doi.org/10.1111/dth.15275 Text en © 2021 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Articles Grada, Ayman Del Rosso, James Q. Graber, Emmy Bunick, Christopher G. Stein Gold, Linda Moore, Angela Y. Baldwin, Hilary Obagi, Zaidal Damiani, Giovanni Carrothers, Timothy McNamee, Brian Hanze, Eva Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
title | Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
title_full | Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
title_fullStr | Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
title_full_unstemmed | Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
title_short | Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
title_sort | sarecycline treatment for acne vulgaris: rationale for weight‐based dosing and limited impact of food intake on clinical efficacy |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286649/ https://www.ncbi.nlm.nih.gov/pubmed/34923732 http://dx.doi.org/10.1111/dth.15275 |
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