Empatic™ - The Next Super Diet Pill?

Orexigen has announced that their promising new weight loss pill, Excalia, now has a new name - Empatic™.

In November, 2006, Orexigen reported that the United States Patent and Trademark Office (USPTO) has issued a patent covering the composition of Orexigen's Empatic™,(formerly Excalia™) which is now in a phase IIb clinical trial for the treatment of obesity. The underlying science behind this patent was made by Dr. Kishore Gadde at Duke University and covers the use of various combinations of weight-loss promoting anticonvulsants with compounds that enhance the activity of norepinephrine or dopamine. This includes Empatic's ingredients, zonisamide, an anticonvulsant, in combination with bupropion, a norepinephrine and dopamine reuptake inhibitor. U.S. Patent No. 7,109,198 B2 was awarded to Duke University and is exclusively licensed by Orexigen.

This information was reported in a press release by Orexigen on November 9, 2006. The entire release can be seen at http://ir.orexigen.com/releasedetail.cfm?ReleaseID=224840.

Empatic™ Phase IIb Results Reported

Orexigen™ announced on July 24, 2007, that the 24 week primary endpoint of its Phase IIb trial of Empatic™ (formerly Excalia™), one of its two obesity drug candidates, has shown positive results. The trial has shown a statistically significant weight loss as measured against against placebo (p less than .001).

The phase IIb trial, which was conducted with the Orexigen's™ novel sustained release (SR) formulation of zonisamide paired with bupropion SR, evaluated various ratios of bupropion and zonisamide in 620 patients. At the highest dose tested, patients experienced 8.6% weight loss from baseline compared to 1.1% weight loss for placebo in the intent-to-treat group, and 10.3% weight loss from baseline compared to 1.2% weight loss for placebo in the completer group. In addition, the trajectory of weight loss for all 6 treatment arms appeared to continue downward through 24 weeks.

The drug regimen seemed to be tolerated better at all dosage levels, than earlier trials with the immediate release version of zonisamide. About 14% discontinued treatment as opposed to 37% with the immediate release version.