Lorcaserin is a new 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.
Arena pharmaceuticals released a press release in late 2009 in which they said that any subjects taking Lorcaserin twice a day can expect to lose 5% or more of their weight after year. They further stated that the average weight loss for participants who have taken Lorcaserin was approximately 12.7 pounds a year. Lorcaserin is known as an agonist. This merely means that it is able to initiate a psychological response when effectively combined with a receptor in the brain. In this case it is the hypothalamus, which actively controls your body temperature, your thirst, your hunger, sleep and many other emotional activities.
Once Lorcaserin has activated this receptor, this will trigger the production of serotonin, while inhibiting the production of dopamine. Dopamine is best known as an internal chemical substance that is most associated with our mood, attention and motivation. However this so-called “miracle” diet drug has received much negative press. The Proceedings of the National Academy of Sciences (PNAS) has recently published their findings into the activation of the hypothalamus receptor. It is believed that the majority of suicide victims have an abnormally high number of these receptors in the brain. This could, in turn, mean that using Lorcaserin to treat obesity may possibly cause and even lead to depression. Many researchers are extremely concerned that this drug and other similar ones can contribute to depression and possible suicidal thoughts.
There are certain side effects that are associated with Lorcaserin and these include – headaches, dizziness and nausea. Additionally we are now aware that it is potentially connected to depression and anxiogenic symptoms. As of December 2009, Arena pharmaceuticals submitted a new drug application (NDA) for Lorcaserin to the FDA. This application cited 18 clinical trials that had tested the drug on a total of 8,576 patients. This application was accepted into February 2010 and the FDA issued and assigned a prescription drug user fee act (PDUFA). This application will be reviewed on October 22, 2010.
Lorcaserin has recently been through a phase III pivotal program. This program consists of BLOOM (behavioural modification and Lorcaserin for overweight and obesity management) and BLOSSOM (behavioural 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 (behavioural modification and Lorcaserin for overweight and obesity management in diabetes mellitus).
The main effects of these trials after one year are as follows:
There are numerous studies that have shown that a weight loss of 5% to 10% is actually extremely significant in medical terms. It can significantly improve the cardiovascular risk factors and may even reduce the incidence of type II diabetes in certain patients who suffer from a glucose intolerance. It is estimated that approximately 65% of US adults are overweight or obese. It is further believed that the medical costs associated with obesity are close to $150 billion per annum. Therefore anything that can help to significantly reduce these figures must be taken seriously.
Arena pharmaceuticals have spent the majority of 2010 attending numerous biotechnology and pharmaceutical conferences. They have even hosted several conferences themselves in order to discuss their phase III results. In the main, the reaction to these conferences has been much confusion and, in all honesty, the market is actively waiting in anticipation of possible FDA approval.