Nearly a year after the weight loss drug BELVIQ was officially approved by The Food and Drug Administration (FDA), it is now available to patients by prescription in US pharmacies.
BELVIQ (trade name for the drug compound lorcaserin hydrochloride) is the first weight loss drug approved by the FDA in 13 years. It is used for chronic weight management in adults with overweight or obesity as an addition to a reduced-calorie diet and exercise.
The launching of BELVIQ in the United States was delayed due to a pending review and final scheduling designation by the Drug Enforcement Agency (DEA). The DEA’s final ruling was issued in May 2013, removing the last obstacle for it’s market debut.
Oversight by the DEA was required in addition to FDA approval because the substance lorcaserin is a new chemical entity with central nervous system hallucinogenic properties.
The action declared the drug has a low potential for abuse and currently has an accepted medial use in the United States. It placed lorcaserin into Schedule IV of the Controlled Substances Act (CSA) – the second least-restrictive designtation on a 5-step scale.
This favorable designation allows physicians of any specialty, including general practitioners, to liberally prescribe BELVIQ to patients through local pharmacies.
The DEA also confirmed physicians can legally combine Belviq-Phentermine when appropriate to accelerate weight loss benefits.
BELVIQ was developed and discovered by Arena Pharmaceuticals as a treatment for obesity.
The new drug compound is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.
The medication comes in a 10 mg film-coated tablet for oral use that is taken twice daily.
It is approved for use in adults with a body mass index of 30 or greater (obesity), or with a BMI of 27 or greater (overweight) and at least one weight-related health condition such as type 2 diabetes, high blood pressure, high cholesterol, heart disease, or sleep apnea. It should not be taken by women who are pregnant, who are planning to become pregnant, or by women who are nursing.
The most common side effects of Belviq in patients without diabetes are headache, dizziness, fatigue, nausea, dry mouth, and constipation; and in patients with diabetes are hypoglycemia (low blood sugar), headache, back pain, cough, and fatigue.
Patients can learn more about BELVIQ online at www.belviq.com.
Weight Loss Results
BELVIQ was evaluated in three clinical trials. Study participants were randomized to either BELVIQ or PLACEBO for one year. Both groups were counseled to eat a reduced-calorie diet (600 fewer calories per day) and exercise at a moderate level (30 minutes a day).
Average weight loss in participants taking Belviq compared to the placebo group ranged from 3 percent to 3.7 percent, or about 6 pounds more weight loss.
About 47 percent of participants WITHOUT type 2 diabetes lost at least 5 percent of their body weight compared to 23 percent of the placebo group; about 38 percent of participants WITH type 2 diabetes lost at least 5 percent of their body weight compared to 16 percent of the placebo group.
Cost and Insurance Coverage
BELVIQ is expected to cost about $140-150/month per patient. Aetna and Blue Cross have already announced coverage for BELVIQ and other insurance companies might do the same.
Weight Loss Medications and Weight Loss Surgery
Weight loss medications can be an important step in the treatment process of obesity. They can help people curb their appetite and jump start weight loss efforts.
For patients looking into weight loss surgery, many insurance companies will approve coverage only after patients provide documented evidence of failed weight loss attempts with non-surgical treatment methods, including diet programs and medical therapy.
Weight loss medications can be part of an effective medically supervised treatment program that precedes surgical intervention.