Vivus – Makers Of Qsymia

Vivus is a biopharmaceutical company that develops innovative, next-generation therapies to address unmet needs of individuals with obesity, diabetes, sleep apnea and sexual health for the United States, Europe and other world markets.

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For those of you not familiar, a biopharmaceutical also referred to as a biologic can be any pharmaceutical drug product that is manufactured in, extracted from, or semi synthesized from a biological system.

Qsymia maker - Vivus

​Vivus is a relatively small pharmaceutical company that is headquartered in Mountain View, California.  They recently developed an erectile dysfunction (ED) drug know as Avanafil.  Avanafil has completed Phase 3 trials and has been approved by the FDA and will be sold under the name Stendra.  Stendra is the first and only oral ED therapy approved to be taken about 15 minutes before sexual activity.

Vivus has also developed an obesity drug known as Qnexa which is now known as Qsymia.  It is a combination of phentermine and topiramate.  Phentermine and topiramate are known as weight loss drugs.  Qsymia was approved by the U.S. Food and Drug Administration (FDA) in mid 2012.  Qsymia is an extended release capsule that acts as an appetite suppressant that decreases your craving for food thereby decreasing your daily caloric intake allowing you to lose weight.  The drug was approved for individuals with a BMI of 27 or greater who have at least one weight-related condition such as diabetes type-2, high cholesterol or high blood pressure.

Vivus Phentermine

​The Medical Affairs Department of Vivus bridges research, clinical development, scientific publications, health outcomes, bio-statistics, medical education and many other medical services.  They provide health care professionals, key opinion leaders, regulatory agencies, professional agencies and groups as well as physicians with medical and scientific information about education.  Vivus created the most popular diet pill with Phentermine in the world – Qsymia, combination of Phentermine and Topiramate.

Qsymia – What Is It?

​Qsymia is a prescription weight loss drug approved by the FDA that contains a combination of immediate-release Phentermine and extended-release Topiramate (Topamax) in an extended-release capsule.  Originally developed by Vivus.

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​Phentermine is labeled as an appetite suppressor that has some similarities to amphetamines and Topiramate is a seizure drug (anticonvulsant). Qsymia is a mixture of these drugs and used as a chronic weight management program along with behavior changes, diet restrictions and exercise.

​Two large clinical trials (1 year each) were conducted for 56 weeks on Qsymia that involved 3,754 patients who had BMIs (Body Mass Index) of 30 or greater, or 27 or greater with two or more weight-related issues such as diabetes type-2, hypertension or dyslipidemia (high cholesterol). Patient’s weight loss and waist circumference were recorded. A subset of patients (N=2,076) with a baseline BMI of 30 or greater were reported. The patients were randomized to a placebo, Phentermine 3.75 mg/Topiramate 23 mg, Phentermine 7.5 mg/Topiramate 46 mg, or Phentermine 15 mg/Topiramate 92 mg. These patients were recommended to eat a well-balanced diet and to reduce their caloric intake by 500 Calories a day. Qsymia is reported to help you lose 24 pounds or more and help you keep it off, lose 4 inches or more off your waist and achieve 10 percent average percent weight loss. Keep in mind that your results may vary depending on your particular BMI, exercise, diet, dosage, age and gender.

​Ultimately, Qsymia helps you in two ways to meet your weight loss goals. It helps to decrease hunger that is to say take away your cravings for food while making you feel full throughout the day. This helps to keep you from snacking and overeating when you have meals. How Qsymia works is not well understood at this time.

Those Who Should Not Take Qsymia

  • Pregnancy – do not take Qsymia if you are pregnant, planning to become pregnant or breastfeeding. This drug is listed as an FDA pregnancy Category X. Qsymia may pass into breast milk and potentially harm your newborn. Qsymia can pass into the fetus and potentially cause birth defects such as cleft palate.
  • Glaucoma – serious eye problems may occur while on Qsymia if you have glaucoma. Look for any sudden decrease in vision with or without eye pain and redness. Qsymia can cause blockage of fluid in the eye which can cause an increase in eye pressure (secondary angle closure glaucoma). These symptoms can lead to permanent vision loss if not treated promptly.
  • Thyroid problems – if you have hyperthyroidism, you should not take Qsymia.
  • Monoamine oxidase inhibitors – if you are taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days, do not take Qsymia.
  • Allergies – do not take Qsymia if you are allergic to cold medications, dyes, Phentermine or related amines, Topiramate or any other ingredients that may be in Qsymia such as binders and fillers.
  • Stroke – if you’ve had a heart attack or stroke in the past, Qsymia may not be for you. Talk with your healthcare provider and see what he/she says.

QSYMIA – WHAT’S THE COST AND DIFFERENT CONFIGURATIONS

​Qsymia is a weight loss drug in an extended-release form that is a combination of Phentermine and Topiramate. Phentermine is used to suppress appetite and Topiramate is used primarily to treat epilepsy and prevent migraines. Topiramate has a common side effect of generating weight loss and enhances the effects of Phentermine. Qsymia has no generic alternative available at this time.

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  • Dosage forms and strengths:
  • Capsules (Phentermine mg/Topiramate mg extended-release)
  • 3.75 mg/23 mg (starting dose)
  • 7.5 mg/46 mg (recommended dose)
  • 11.25 mg/69 mg (titration)
  • 15 mg/92 mg (highest dose)

Qsymia 3.75 mg/23 mg and 11.25 mg/69 mg are for titration purposes.

Indications and Usage

Qsymia is used in conjunction with a reduced-calorie diet and exercise for chronic weight management in adults who have an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (medically obese), or
  • 27 kg/m2 or greater (overweight) and at least one weight related comorbidity such as diabetes type-2, high cholesterol or hypertension.

General Dosing and Administration

​For those of you who are not familiar with body mass index (BMI), we’ll take a look at it here. BMI is calculated by dividing your weight (in kilograms) by height (in meters) squared. You can use a conversion chart from the internet to use pounds and inches.

If you have an initial BMI of 30 or greater or 27 with comorbidities, your dosage of Qsymia would be:

Start therapy with one capsule of Qsymia (3.75 mg/23 mg) daily for 14 days taken in the morning with or without food. After 14 days increase to the recommended dose of Qsymia 7.5 mg/46 mg once daily.

  • Weight will be evaluated after 12 weeks. If the patient has not lost at least 3 percent of their baseline weight, discontinue or raise the dose. To raise the dose, increase to one capsule 11.25 mg/69 mg for 14 days once daily.
  • After 12 weeks of treatment, evaluate weight loss again.
  • If patient has not lost 5 percent of baseline weight, therapy is discontinued.

Qsymia Cost

Initially, Vivus (manufacturer of Qsymia) didn’t expect private or public insurances to pay for Qsymia prescriptions so you will probably have to pay out of pocket. According to WebMD, the wholesale price of Qsymia for a 30 day supply is: (Phentermine mg/Topiramate mg)

  • Low dose (starting dose) – 3.75 mg/23 mg – $120.00
  • Recommended doses – 7.5 mg/46 mg – $135.62
  • Three-quarter dose – 11.25mg/69 mg – $162.74
  • Top dose – 15 mg/92 mg – $183.90

The above prices are what the pharmacies pay, not you.  Online, 30 day supply may cost as much as following:

  • Low dose (starting dose) – 3.75 mg/23 mg – $185 to $245
  • Recommended doses – 7.5 mg/46 mg – $193 to $257
  • Three-quarter dose – 11.25mg/69 mg – $207 to $266
  • Top dose – 15 mg/92 mg – $206 to $266

Currently, Qsymia is available at Kroger, Target (CVS), Walgreens, Safeway, Walmart, Sams Club, Rite-Aid, CVS pharmacies, Publix and Kmart. There are coupons and discounts available for Qsymia. Check out PhenObestin – Qsymia alternative without prescription. Some other sites offer a start Qsymia for free program and you can continue to save for 36 months. These sites usually say you’ll get the first 14 days free (3.75 mg/ 23 mg) starter dose or you can opt for saving up to $95 on your first 30 day prescription at any dose. From there you can save up to $65 per month for 36 months. This monthly saving offer requires an activated Program ID prior to use. You must have a valid prescription. Also, search for Qsymia coupons on the internet.