– A new path in weight management is now available
– UAE is the first country in the Middle East to have QSYMIA® available
– Rising obesity rates cost UAE nearly $12 billion annually
CAMPBELL, Calif., March 10, 2025 (GLOBE NEWSWIRE) — VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, announced the market approval of QSYMIA® (phentermine and topiramate extended–release capsules) CIV in the United Arab Emirates (UAE) for treatment of overweight and obesity in adults and pediatric patients, age 12 and older. The UAE is the first country in the Middle East region to approve QSYMIA and have it available in market. This marks an important milestone for patients challenged by obesity and the physicians who treat them.
VIVUS, in collaboration with PharmaAccess, its marketing partner in the Middle East North African (MENA) region, intends to provide healthcare providers with more treatment options to combat this epidemic in line with the UAE vision to address obesity. Alphamed Drug Store is the exclusive distributor of QSYMIA in the UAE.
“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. We are enthusiastic about our continued progress in combatting this urgent public health concern, making a meaningful impact in communities worldwide.”
The World Obesity Federation estimates that by 2035, approximately 7.5 million adults, children, and adolescents in the UAE will be overweight or living with obesity. This statistic underscores the severity of the obesity challenge in the UAE, revealing potential detrimental effects on the health of affected individuals and the nation's economy, now and in the foreseeable future.
“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 VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “At VIVUS, our mission is to provide patients worldwide with a sustainable path to lasting weight management. This milestone marks a significant step forward in advancing those efforts.”
Obesity is forecasted to affect one billion individuals globally by 2030, nearly double that in 2020. In response to the substantial health and economic burdens of the obesity epidemic, VIVUS is expanding access to QSYMIA to patients in multiple European countries, which will be sold under the trade name QSIVA® (phentermine and topiramate modified–release). VIVUS plans to provide access to QSYMIA to over one billion individuals worldwide by the end of 2025.
QSYMIA, in combination with a reduced–calorie diet and exercise, has been proven to help adults and children ages 12 – 17 lose weight and maintain the loss. It is indicated for long–term use.
About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit http://www.vivus.com.
About PharmaAccess
PharmaAccess partners with pharmaceutical and biotech companies that are willing to enter the GCC market and be positioned among the top–performing companies in the region. It offers its partners fully integrated solutions by executing a range of commercial functions.
About QSYMIA
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 pediatric 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 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.
For more information on QSYMIA, please visit https://QSYMIA.com/
About QSIVA
QSIVA (the European brand name for QSYMIA) is approved in Sweden, Denmark, Finland, Iceland, Norway, and Poland. QSIVA is indicated as an adjunct to a reduced–calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight–related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The effect of QSIVA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSIVA in combination with other products intended for weight loss, including prescription and over–the–counter drugs and herbal preparations, have not been established. For more information on QSIVA, please visit www.QSIVA.eu.
Important Safety Information for QSYMIA
Do not take QSYMIA if you are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA.
Common side effects of QSYMIA in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia), dizziness, changes in the way foods taste or loss of taste (dysgeusia), trouble sleeping (insomnia), constipation, and dry mouth. Common side effects of QSYMIA in children aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain.
QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), increases in heart rate, visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, serious eye problems, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older.
Important Safety Information for QSIVA
QSIVA (phentermine and topiramate modified–release) hard capsules is contraindicated in pregnancy and in women of childbearing potential who are not using effective methods of contraception; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in QSIVA.
QSIVA can cause fetal harm. It is recommended that patients who can become pregnant obtain a negative pregnancy test result before starting QSIVA treatment, perform monthly pregnancy testing, and use effective contraception while taking QSIVA. If a patient becomes pregnant while taking QSIVA, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most common adverse reactions in adults are paraesthesia, dizziness, an altered or impaired sense of taste, insomnia, constipation, and dry mouth.
Forward–Looking Statements
Important Information and Cautionary Note Regarding Forward–Looking Statements
Certain statements in this press release are forward–looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward–looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company’s management. These statements may be identified by the use of forward–looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward–looking statements included in this document are based on our current expectations, and the Company assumes no obligation to update any such forward–looking statements except to the extent otherwise required by law.
Forward–looking information about QSYMIA, including its potential benefits, approvals in potential markets outside the U.S. and anticipated product availability, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other markets or approved, whether QSYMIA will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSYMIA; uncertainties regarding the impact of COVID–19 on our business, operations, and financial results; and competitive developments.
The above factors, risks and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results and may be beyond the Company’s control. New factors, risks and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks and uncertainties. Although the Company believes that the assumptions underlying the forward–looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward–looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward–looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward–looking statements, whether as a result of new information, future events, changes in underlying assumptions or otherwise, unless otherwise required by law.
Contacts
VIVUS LLC
T: +1 (650) 934–5200
Media – FINN Partners
Glenn Silver
[email protected]
T: +1 973–818–8198
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