Weight Loss Medicine and Prescriptions - Lorcaserin

Lorcaserin is a weight loss drug that is currently in the final stages of clinical testing and awaiting FDA approval. Lorcaserin has been manufactured and developed by Arena pharmaceuticals and can best be described as a serotonin enhancing prescription drug. It is believed that if you are able to manipulate your serotonin levels, this should help you to suppress your appetite, reduce cravings, eat less and eventually this will lead to weight loss.

Lorcaserin works by activating a very specific receptor on brain cells. This in turn leads to decreased appetite. Lorcaserin has recently been through a phase III pivotal program. This program consists of BLOOM (behavioral modification and Lorcaserin for overweight and obesity management) and BLOSSOM (behavioral modification and Lorcaserin second study for obesity management) trials. These trials evaluated 7,190 patients over a period of two years. During this two-year trial the safety and efficiency of Lorcaserin for weight management in obese and overweight patients is being tested. There is also an additional trial for patients who also suffer from type II diabetes and is known as BLOOM-DM (behavioral modification and Lorcaserin for overweight and obesity management in diabetes mellitus).

The main effects of these trials after one year are as follows:

  • Approximately 66% of the patients achieved at least a 5% weight loss. Over 33% managed to achieve a 10% weight loss
  • The average weight loss was 8% or 17-18 pounds
  • It was found that both the heart rate and blood pressure went down
  • Lorcaserin produced no signs of depression or suicidal tendencies and actually managed to improve the quality of life
  • The only real negative event was that certain patients suffered from mild or moderate headaches

ADVERSE REACTIONS

The most common side effect noticed over trial periods were Headache, which was experienced by about 18% of drug arm participants compared to 11% of placebo participants. Headache was the only reported side effect to occur at a frequency greater than 5 percentage points above placebo. Other reported side effects and their rates for lorcaserin and placebo patients, respectively, were as follows: upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group.

About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, Lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for Lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for the review of the application.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.

Cost, will it be paid by insurance?

It is not decided yet as FDA approval is still pending
However as per the reviews given by Steven Vig (MD internal medicine) Tucson, Arizona
Health insurance companies may need to reconsider health insurance policy if Lorcaserin is fda approved. A new drug is usually placed in one of three categories by a health insurance:

Category one would be “not covered under any circumstances",
Category two would be "covered without prior authorization"
Category three would be "covered with prior authorization".

The copy on a covered drug is least expensive for a generic, more expensive for a brand name preferred drug, and most expensive for a brand name non-preferred drug. If the Lorcaserin was available on a prior authorization basis, the physician must first fax in a paper to the health insurance company to ask that the drug be covered for a particular patient. The health care company might cover Lorcaserin if it was for obesity associated with diabetes, but might not cover it if a patient was overweight but with no associated diseases like diabetes or high blood pressure or high lipids or sleep apnea. Certainly, if the patient can not get the drug covered through the health insurance, it can be purchased for cash. This is where the pricing of Lorcaserin is important. We can hope that Arena prices Lorcaserin in a way that would be affordable to most patients. The profit on a drug depends both on price and volume sold. we hope that Arena prices the drug a little lower and looks to make up the difference with higher volume sold.