While we await Acomplia news, along comes a report from the small biotech company Arena Pharmaecuticals that its experimental obesity drug APD356 was effective at three different doses in promoting weight loss in a three-month phase 2 clinical trial.
At the highest 20 mg dose, the drug produced an average weight loss of 7.9 pounds, or about 3.6 percent of a participant's starting body weight, compared to a .7 pound loss for those taking a placebo. The lower doses were proportionately less effective.
The study, which enrolled 469 obese patients -- overwhelmingly women -- with a body mass index (BMI) of between 29 and 46, did not include any diet or exercise programs.
"This trial demonstrated excellent weight loss, particularly considering there was no diet or exercise component in this trial and the emerging safety and tolerability profile compares favorably with other weight loss drugs," lead researcher Dr. Steven Smith said in a statement.
This compound targets a different serotonin receptor than Fen-Phen and dexfenfluramine, and the most common side effects from APD356 reported from the short trial were headache and nausea. No severe side effects were attributed to the use of the drug.
The company said it hoped to begin the larger, longer Phase III trials needed for approval of a new drug in mid-2006. If all goes well (always a big if with new drugs), Arena could be in a position to apply for U.S. FDA approval in 2009 and could possible launch in 2010.
|