Phentermine/Topiramate: Pediatric First Approval

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.