Lorcaserin for Weight Management
Our 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. In December 2009, we submitted a New Drug Application, or NDA, for lorcaserin to the FDA. The NDA submission is based on an extensive data package from lorcaserin’s clinical development program that includes 18 clinical trials totaling 8,576 patients.
The lorcaserin Phase 3 program consists of three trials, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Enrollment in the lorcaserin Phase 3 program is complete with approximately 7,800 patients.
BLOOM and BLOSSOM comprise the pivotal Phase 3 program and are the basis for the NDA submission. In addition to the pivotal program, we are evaluating lorcaserin in obese and overweight patients with type 2 diabetes in our BLOOM-DM trial. BLOOM-DM is planned as a supplement to the NDA.
The pivotal Phase 3 clinical trial program evaluated nearly 7,200 patients treated for up to two years, and showed that lorcaserin consistently produced significant weight loss with excellent tolerability.
The BLOOM and BLOSSOM results were comparable, and demonstrated the following key lorcaserin effects after one year of treatment:
- About two-thirds of patients achieved at least 5% weight loss and over one-third achieved at least 10% weight loss
- On average, patients lost 17 to 18 pounds or about 8% of their weight
- Secondary endpoints, including body composition, lipids, cardiovascular risk factors and glycemic parameters improved compared to placebo
- Heart rate and blood pressure went down
- Lorcaserin did not increase the risk of cardiac valvulopathy
- Lorcaserin improved quality of life, and there was no signal for depression or suicidal ideation
- The only adverse event that exceeded the placebo rate by 5% was generally mild or moderate, transient headache
We have performed some post-hoc analyses of data from the individual pivotal trials that demonstrate how well lorcaserin works:
- Based on a normal BMI of 25, BLOOM patients lost about one-third of their excess body weight
- The average weight loss was 35 pounds or 16% of body weight for the top quartile of BLOSSOM patients
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. We have patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity we might obtain.
About Weight Management
The National Institutes of Health reported in 2007 that about 65% of US adults are overweight or obese. A 2009 publication in Health Affairs estimated the annual medical burden of obesity in the US to be $147 billion in 2008. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes in patients with glucose intolerance.
The FDA draft guidance document “Developing Products for Weight Management” dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
(This page was last updated: January 5th, 2010. Additional information regarding Arena is available in its SEC filings.)
