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Phentermine/Topiramate: Pediatric First Approval

Sohita Dhillon1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Paediatric Drugs
|September 4, 2022
PubMed

Insights

Phentermine/topiramate extended-release (Qsymia) is now approved for chronic weight management in adolescents aged 12 and older. This marks a significant milestone for pediatric obesity treatment, offering a new therapeutic option.

Area of Science:

  • Pharmacology and Therapeutics
  • Pediatric Medicine
  • Obesity Management

Background:

  • Phentermine/topiramate extended-release (Qsymia) is a combination drug developed for obesity and related conditions.
  • It functions by reducing appetite and increasing satiety.
  • The drug is being investigated for sleep apnea, type 2 diabetes, and non-alcoholic steatohepatitis (NASH).

Purpose of the Study:

  • To summarize the developmental milestones of phentermine/topiramate.
  • To highlight the first approval for chronic weight management in pediatric patients.
  • To provide context for its expanded therapeutic applications.

Main Methods:

  • Review of developmental and regulatory milestones.
  • Analysis of clinical development for various indications.
  • Focus on the pediatric first approval in the USA.

Main Results:

  • Phentermine/topiramate received its first approval in July 2022 in the USA.
  • The approval is for pediatric patients aged 12 years and older with a BMI in the 95th percentile or greater.
  • The drug is also approved for adult obesity in the US and South Korea.

Conclusions:

  • The pediatric approval represents a significant advancement in adolescent obesity management.
  • Ongoing clinical development targets sleep apnea and type 2 diabetes in obese patients.
  • Preclinical development is underway for NASH treatment.

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