Nearly a year after its FDA approval, Lorcaserin, more commonly known as Belviq, will be available to patients through prescription. Lorcaserin was the first diet pill to be approved by the FDA since Orlistat’s (Alli) approval in 1999, but it was beat to the market by Qsymia. Qsymia has been plagued by weak sales since it first appeared on the market 10 months ago. Arena, the company that sells Belviq, is hoping that their product does considerably better.
Belviq is approved for those who are obese, as well as those who are overweight with other serious health risks like diabetes. It works by targeting the serotonin receptors, specifically the 2C receptor, in the brain to help the patient feel full. This receptor is in the area of the brain associated with appetite control and metabolism.
Vivus Inc. has released a diet pill called Qsymia – one of only two diet pills (the other being Belviq) to be released in the last 13 years. Vivus applied intense pressure on the FDA earlier this year to approve the obesity-targeted drug for for the two-thirds of Americans who have a body fat percentage high enough make them obese.
The problem? Qsymia shares were down 24 percent on Tuesday. Since their launch mid-September, they’ve only seen $41,000 in sales. Analysts were expecting around $310,000 by this point.
Vivus Inc. Chief Commercial Officer Mike Miller stated his concern over the pill’s insurance coverage.
“About 30 percent of patients chose not to fill after receiving a [Qsymia] prescription due to cash outlay,” he said. “The average retail price for the patient for 30 days or the recommended dose is approximately $160. Currently, we’re seeing one out of five [patients] being covered by third-party insurance with an average co-pay of $62.” (more…)
The Doctors investigate some weighty topics on their show today, including what they think about the new FDA-approved weight loss pills. The pills, Belviq and Qsymia, are the first to be approved by the government administration since 1999. Dr. Travis talks about their efficacy and side effects to determine whether he thinks they are safe or not.
Then, The Doctors turn to the deadly meningitis outbreak. They discuss how it happened, the signs and symptoms, and what to do if you think you may be infected. (more…)
There are mixed reviews about the recent approval of lorcaserin (Belviq) and its new availability as a prescription weight loss drug. Obesity has become an epidemic in the United States and across the world and the maker of lorcaserin, Arena Pharmaceuticals, will market this drug as a supplement to drug and exercise to help patients reach their weight loss goals faster. Every drug has side effects and I felt it was important to look closer at some of the possible reactions.
Lorcaserin activates the serotonin 2C receptor which helps you eat less and feel full sooner. Previous weight loss drugs activated the 2B receptor and caused damage to heart valves. Cardiovascular health will be monitored once this hits the market to ensure no damage to the heart valves occur, as there were concerns about this in trials. In October 2010, lorcaserin was rejected by the FDA due to a cancer signal being detected. It caused mammary tumors in rats, which the makers believe is related to the animal themselves and should not have the same effect in human subjects (although prolactin levels can become increased in humans leading to breast development in men and lactation in women).
Multiple studies had patients with and without diabetes treated long term for one to two years with nearly 8,000 patients participating. Those who were randomized with lorcaserin along with diet and exercise counseling lost 3 to to 3.7 percent more weight. The drug should be discontinued if the patient does not lose at least five percent of their body weight in the first twelve weeks. (more…)
It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?
Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.
“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.
The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.
“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.” (more…)