VIVUS LLC has announced the market approval and launch of its weight management medication QSYMIA® (phentermine and topiramate extended-release capsules) in the United Arab Emirates (UAE), marking the first entry of this obesity treatment into the Middle East region. The medication is approved for treating overweight and obesity in adults and pediatric patients aged 12 years and older.
The UAE approval represents a significant milestone in VIVUS's global expansion strategy and addresses a critical public health challenge in the region. According to company officials, the medication will be distributed exclusively by Alphamed Drug Store in the UAE, with marketing support from PharmaAccess, VIVUS's partner in the Middle East North Africa (MENA) region.
Addressing a Growing Public Health Crisis
Obesity represents a substantial and growing health burden in the UAE. The World Obesity Federation projects that by 2035, approximately 7.5 million adults, children, and adolescents in the UAE will be overweight or living with obesity. The economic impact is equally concerning, with obesity-related costs in the UAE estimated at nearly $12 billion annually.
"VIVUS remains steadfast in its mission to tackle the obesity crisis head-on," said John Amos, Chief Executive Officer at VIVUS LLC. "With the availability of QSYMIA in the UAE, we're not only expanding treatment access but also reaffirming our commitment to advancing patient care on a global scale."
The global obesity epidemic continues to accelerate, with projections indicating that one billion individuals worldwide will be affected by 2030—nearly double the number from 2020. This dramatic increase underscores the urgent need for effective treatment options.
Treatment Mechanism and Clinical Application
QSYMIA combines two established medications: phentermine, an appetite suppressant, and topiramate, an anticonvulsant that also contributes to appetite reduction and increased feelings of fullness. The extended-release formulation is designed to be used in conjunction with a reduced-calorie diet and increased physical activity.
Clinical data supports QSYMIA's efficacy in helping both adults and adolescents lose weight and maintain weight loss over time. The medication is indicated for long-term use in patients with obesity, defined as a Body Mass Index (BMI) of 30 kg/m² or greater, or in overweight adults (BMI ≥27 kg/m²) who have at least one weight-related comorbid condition such as hypertension, type 2 diabetes, or dyslipidemia.
"By providing access to QSYMIA, the UAE can make a difference in the lives of those impacted by obesity, addressing the challenges of this multifaceted condition and mitigating its economic repercussions," said Santosh T. Varghese, MD, President of VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC.
Global Expansion Strategy
The UAE launch is part of VIVUS's broader international expansion plan. The company has already secured approvals for the medication in several European countries, including Sweden, Denmark, Finland, Iceland, Norway, and Poland, where it is marketed under the trade name QSIVA® (phentermine and topiramate modified-release).
According to company statements, VIVUS aims to provide access to QSYMIA to over one billion individuals worldwide by the end of 2025. This ambitious goal reflects both the scale of the global obesity epidemic and the company's commitment to addressing it.
Safety Considerations
As with all medications, QSYMIA comes with important safety considerations. The drug is contraindicated during pregnancy due to risk of birth defects, in patients with glaucoma or hyperthyroidism, and in those taking monoamine oxidase inhibitors (MAOIs).
Common side effects reported in adults include paraesthesia (numbness or tingling in extremities), dizziness, dysgeusia (altered taste sensation), insomnia, constipation, and dry mouth. In pediatric patients aged 12 years and older, common side effects include depression, dizziness, joint pain, fever, flu, and ankle sprain.
More serious potential side effects include birth defects, increased heart rate, visual field defects, suicidal thoughts or actions, serious eye problems, and severe skin reactions. The medication may also slow height increase in pediatric patients.
Market Impact and Future Outlook
The introduction of QSYMIA to the UAE market provides physicians with an additional tool to address obesity, which is increasingly recognized as a chronic disease requiring medical intervention rather than simply a lifestyle issue.
With obesity rates continuing to rise globally and in the Middle East specifically, the availability of pharmacological treatments like QSYMIA represents an important complement to dietary, exercise, and behavioral interventions. The medication's approval for use in adolescents is particularly significant given the rising rates of childhood obesity worldwide.
As VIVUS continues its global expansion, the company will likely face both opportunities and challenges, including varying regulatory environments, healthcare system differences, and competition from newer weight management medications that have entered the market in recent years.
