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Phentermine/Topiramate: Pediatric First Approval

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Abstract

Phentermine/topiramate extended-release capsule (Qsymia®) is a fixed-dose combination of phentermine and topiramate, which is being developed by VIVUS (a subsidiary of Icahn Enterprises) for the treatment of obesity, sleep apnoea syndrome, type 2 diabetes mellitus and non-alcoholic steatohepatitis (NASH). The once-daily formulation of phentermine (a sympathomimetic amine) and topiramate is designed to combat obesity by decreasing appetite and increasing satiety. In July 2022, phentermine/topiramate received its first approval in the USA, as an adjunct to a reduced-calorie diet and increased physical activity, for chronic weight management in pediatric patients aged ≥ 12 years with BMI in the 95th percentile or greater standardized for age and sex. Phentermine/topiramate is approved in the US and South Korea for obesity in adults. Clinical development of phentermine/topiramate for sleep apnoea syndrome and type-2 diabetes in obese patients and preclinical development for NASH is ongoing in the US. This article summarizes the milestones in the development of phentermine/topiramate leading to this pediatric first approval for chronic weight management in adolescents.

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Correspondence to Sohita Dhillon.

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The preparation of this review was not supported by any external funding.

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During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Dhillon, S. Phentermine/Topiramate: Pediatric First Approval. Pediatr Drugs 24, 715–720 (2022). https://doi.org/10.1007/s40272-022-00532-z

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