The results obtained in the phase 2A study were consistent with those observed in preclinical studies, which were conducted last year.
According to the current study, the subjects treated with pramlintide-leptin combo lost an average of 25 pounds, compared with an average of 17 pounds for subjects treated with pramlintide alone.
Amylin has another good reason to get excited about its experimental drug combination - the drug's safety profile. The pramlintide/leptin combination treatment has been found to be safe and the most common side effects seen with the drug were injection site adverse events and nausea, which were mostly mild to moderate and transient in nature. In sharp contrast Roche's diet drug Xenical has been associated with diarrhea, while Abbott Labs' Meridia increases blood pressure or heart rate of some patients.
However, Amylin's pramlintide-leptin combo still has a long way to go before it reaches the shelf of medicine cabinet. The FDA which has been strongly criticized over the safety of approved drugs, having to withdraw some drugs from the market for safety reasons, has become extremely cautious, and passing the FDA muster is also going to be the biggest challenge for the pramlintide-leptin combo. After all, who can forget Wyeth's diet drug combo fen-phen? The drug was pulled off the market in 1997 after it was linked to heart valve disease.
AMLN closed Thursday's regular trade up 2.51% or $1.03 at $42.05 on a volume of 3.52 million shares.
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