Phentermine Hydrochloride/Topiramate

— Presentations spotlight VIVUS’s 13-year track record of leadership with QSYMIA® (phentermine andtopiramate extended-release capsules CIV) in the treatment of obesity and overweight CAMPBELL, Calif., Sept. 04, 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, today announced that Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC, will deliver an oral presentation on advancing obesity management with QSYMIA® (phentermine and topiramate extended-release capsules CIV) at the 2025 International Congress on Obesity and MEtabolic Syndrome (ICOMES), taking place September 4 – 6, 2025 in Seoul, Korea. Additionally, findings from the QUEEN’s study, which was recently published in Diabetes Obesity and Metabolism, will be presented by Sangmo Hong, MD, Hanyang University, Guri Hospital, South Korea. “Over the past 13 years, we have seen firsthand how impactful QSYMIA has been for patients in achieving and maintaining healthy weight goals in the United States,” said Santosh T. Varghese, MD, President of VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “Since receiving market approval in the Republic of Korea in 2019 through our partnership with Alvogen, we have been proud to extend this option to patients globally. At VIVUS, we remain committed to making a difference in this critical public health area and providing patients with therapies that can improve their overall wellbeing.” Details of Dr. Varghese’s presentation at ICOMES are as follows: Symposium: (Symposium 12) Oldies But Goodies, Update on Oral Anti-Obesity MedicationTitle: Advancing Obesity Management: Thirteen Years Strong with Once Daily Oral Phentermine/Topiramate ERPresentation Date & Time: 09:00 – 10:30, September 6 (KST)Location: Room 1 (Grand Ballroom 3) 3F, Conrad Seoul Hotel Dr. Hong will share findings from the study, “Evaluation of the efficacy and safety of controlled-release phentermine/topiramate in adults with obesity in Korea: A randomized, double-blind, placebo-controlled, phase 4 trial (QUEEN’s study).” This phase 4, double-blind, placebo-controlled trial tested the weight-loss drug combination phentermine/topiramate controlled release (PHEN/TPM CR) in Korean adults with obesity and found that adding PHEN/TPM CR to lifestyle changes led to significantly greater weight loss (−8.3% vs. −2.3% with placebo). The QUEEN’s study also demonstrated that weight reduction in the PHEN/TPM CR group was accompanied by decreases in visceral fat, which is closely linked to insulin resistance, type 2 diabetes and heart disease, and body fat percentage, as well as improvements in glucose metabolism. QSYMIA, is a once-daily oral medication that has clinically proven weight management results in adults and children ages 12-17 when combined with a healthy diet and regular exercise. QSYMIA is the leading branded oral product for obesity treatment in the United States with more than four million prescriptions. About VIVUSVIVUS 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 QSYMIAQSYMIA 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/ Important Safety Information for QSYMIADo 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. QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), serious eye problems (secondary angle closure glaucoma), visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older. 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. For more information, please read the QSYMIA Medication Guide, Full Prescribing Information, and Risk of Birth Defects with QSYMIA patient brochure. 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 LLCT: +1 (650) 934-5200 Media – FINN Partners Glenn Silver glenn.silver@finnpartners.com T: +1 973-818-8198