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Giving patients treatment options

VIVUS is dedicated to meeting the needs and improving quality of life of patients with serious medical conditions and life-limiting diseases.

Our commercial products are indicated for the treatment of obese and overweight patients (Qsymia®), exocrine pancreatic insufficiency (PANCREAZE®) and erectile dysfunction (STENDRA®/SPEDRA™). According to the National Institutes of Health, overweight and obesity combined are the second leading cause of preventable death in the United States. Exocrine pancreatic insufficiency (EPI) affects many patient populations, including patients with cystic fibrosis, chronic pancreatitis, celiac disease, diabetes, both type 1 and type 2, inflammatory bowel disease and HIV infection. Erectile dysfunction can lead to reduced quality of life for the millions of men living with the condition.

Please use the links below to learn more about our commercial products.

Approved in the United States – PANCREAZE, Qsymia, STENDRA Approved in Canada – PANCREASE MT Approved in the EU – SPEDRA

Approved in the United States

PANCREAZE logo

PANCREAZE®

(pancrelipase) delayed-release capsules

PANCREAZE is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Warnings and Precautions:

PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.

Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.


Qsymia logo

Qsymia®

(phentermine and topiramate extended-release) capsules CIV

Qsymia 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 comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia

Limitations of Use:

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 and over-the-counter drugs, and herbal preparations, have not been established.


REMS Program

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for Qsymia. For more information visit:


STENDRA logo

STENDRA®

(avanafil)

STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

Warnings and Precautions:

Evaluation of erectile dysfunction (ED) should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.

VIVUS has granted Metuchen Pharmaceuticals LLC exclusive marketing rights to STENDRA in the U.S., Canada, South America and India.

Approved in Canada

PANCREASE® MT

(pancrelipase) delayed-release capsules

Health Canada approved PANCREASE MT for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy.

Warnings and Precautions:

Pancreatic enzyme products, including PANCREASE MT (pancrelipase) have been associated with fibrosing colonopathy (strictures of the ileo-caecum and large intestine) if given at high doses chronically to patients with cystic fibrosis. It is not clear whether this complication is caused by high dosages of pancreatic enzymes, or whether the underlying disease is responsible. Unusual abdominal symptoms should be reviewed to exclude the possibility of colonic damage, especially if the patient is taking in excess of 6,000 lipase units/kg/meal.

PANCREASE MT cannot be substituted (unit for unit) with other pancreatic enzyme products because they are biological products and, therefore, differ in their manufacturing processes, formulations, exact composition, enzymatic activities, stability and bioactivity in the small intestine, so the response of the patient to the estimated dose must be monitored and adjusted as necessary. Special attention to the response of the patient is required during any change in treatment from one pancreatic enzyme product to another.

PANCREASE MT will be marketed by VIVUS subsidiary Willow Biopharma Inc. in the Canadian market but is currently still being marketed by Janssen Canada.

Approved in the European Union

Stendra logo

SPEDRA™

(avanafil)

The European Commission (EC) granted the marketing authorization for SPEDRA (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU).

The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2013. SPEDRA, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade.

VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.


Information for Healthcare Professionals in the EU

A medical information healthcare professional is available to answer questions from healthcare professionals during business hours,
Monday – Friday from 09:00 – 17:00 Local Time, at:

Phone: +31 208–084–787 (Amsterdam)
Phone: +44 203–051–6658 (United Kingdom)

After hours: You may leave a message after hours from 17:00 – 9:00 Local Time, Monday – Friday and all day Sunday, Saturday, and holiday.
If you are a patient, please discuss any questions you may have with your healthcare provider.

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