The FDA has approved a labelling update for VIVUS’ QSYMIA (phentermine and topiramate extended-release capsules CIV) that has removed the specific body mass index (BMI) requirements and warnings or precautions regarding increase in heart rate, risk of hypoglycemia in people with type 2 diabetes taking anti-diabetic therapy and risk of hypotension in people taking antihypertensive medication.
QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight in some adults and certain paediatric patients aged 12 years and older.
The once-daily pill is currently covered by 81% of commercial healthcare plans and is indicated for long-term use. QSYMIA is designed to help patients manage hunger and reduce cravings throughout the day and, combined with a healthy diet and exercise, has been proven to help patients lose, and maintain, weight loss.
QSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and paediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition.
The revised QSYMIA label includes data from the first head-to-head, randomised, double-blind clinical trial of phentermine. The post-marketing study assessed ambulatory blood pressure (ABPM) for eight weeks in patients with overweight or obesity who also had at least one weight-related comorbidity (i.e., hypertension, dyslipidaemia, impaired fasting glucose or glucose tolerance, type 2 diabetes mellitus, or obstructive sleep apnoea).
Key findings from this study include:
The placebo-adjusted difference in systolic blood pressure was –3.2 mmHg for QSYMIA and +1.5 mmHg for phentermine, corresponding to a mean treatment difference of –4.7 mmHg for QSYMIA.
The placebo-adjusted difference in diastolic blood pressure was +1.2 mmHg for QSYMIA and +2.7 mmHg for phentermine, corresponding to a mean treatment difference of –1.5 mmHg for QSYMIA.
The placebo-adjusted difference in heart rate was +3.6 beats per minute (bpm) for QSYMIA and +7.2 bpm for phentermine, corresponding to a mean treatment difference of –3.6 bpm for QSYMIA.
“The updated QSYMIA label simplifies physician decision-making by removing specific BMI targets, enabling greater flexibility and empowering physicians to develop customized treatment plans that support weight loss, have favourable effects on blood pressure, and give patients a choice of treatment modality,” said Dr Santosh T Varghese, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “We believe that QSYMIA provides a differentiated and highly defined safety and efficacy profile with over 12 years of experience in the United States that can help patients achieve and maintain their healthy weight goals without the need for daily injections.”
The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.