Your informational guide to Tesofensine
Orexigen Therapeutics has another obesity medication in development its name was originally Excalia® but has since been changed to Empatic™. Empatic is a combination drug consisting of two already FDA approved medications, zonisamide SR and bupropion SR. Zonisamide is an anticonvulsant, mostly prescribed to adults for epilepsy seizures. Bupropion is sometimes better known as its trademark names Wellbutrin® or Zyban®. Bupropion is a multi use medication acting as an antidepressant and smoking cessation. The SR names after each drug simply stands for the slow release version of them.
Empatic essentially speeds up ones metabolism by affecting chemicals in the hypothalamus. What studies also showed where that there did not seem to be a plateau where the effects seemed to level off but continued right up to the end of the trial period. Some of the common side effects reported with some of the patients where insomnia, nausea and headache. There where no serious unfavorable events that transpired during testing and no measurable difference in depression, psychological issues or even anxiety.
Earlier testing in May 2006 was to determine the optimum dosing amounts. Different amount of the drugs where used in combination over a 24 week study. The study was double-blind, placebo, random consisting of 620 people at 14 different locations.
Weight Loss at 48 Weeks
Zonisamide SR Bupropion SR a b
Group 1 120mg 280mg 10.1% 12.1%
Group 2 120mg 360mg 12.1% 11.8%
Group 3 240mg 280mg 11.8% 12.4%
Group 4 240mg 360mg 12.0% 12.5%
Group 5 360mg 280mg 10.8% 11.0%
Group 6 360mg 360mg 14.0% 15.1%
Group 7 Placebo Placebo 1.1% 1.2%
(placebo group weight loss was at the 24 week point)
The testing rules where that after 24 weeks, the patients continue with their treatment for an additional 24 weeks. However, after 24 weeks, for those who did not meet at least a 5% weight loss were allowed to move to the highest dose test in an extension. The first group is represented by "a" the group that completed the testing through 48 weeks is represented by "b"
Completed stage 2 studies where released in October 2009 its findings showed that Empatic is on the right track to becoming a future obesity medication. Empatic both met and exceeded FDA efficacy guidelines for an effective obesity medication. FDA guidelines that must be met are a body weight reduction of 5% over a 52 week period based on the medication alone. It was reported that during an early stage study, 729 obese people where tested over a 24 week period and nearly three quarters of the patients lost at least 5% of their body weight and nearly half of them lost at least 10% of their weight. Orexigen will most likely now plan out how they will go ahead with phase 3 tests for Empatic. This will be a longer testing phase and with a much larger group of people. If one is looking as to when this drug could be on the market, our guess is perhaps late 2011 or 2012, more likely 2012 (or a 12-18 month period after Contrave) if it makes it to the FDA and they approve it.
Goto the Empatic Forum
This page will be updated with the latested news on Empatic when it becomes available.
Empatic® is the trademarked term for the medication combining Bupropion SR and Zonisamide SR for the treatement of obesity.
Chemical Make Up