UPDATE On Symlin and Extendtide

Amylin confident they will see a positive response from the FDA. Amylin Pharmaceuticals Inc. has provided the U.S. Food and Drug Administration with information it had requested on Symlin, one of two company treatments for diabetes awaiting U.S. marketing approval.

Amylin said the information should adequately answer questions posed by the agency. The FDA has issued two letters saying it could approve the drug subject to certain conditions, including receipt of more information about the medicine.

The FDA last December asked for additional clinical data on Symlin (pramlintide). It had requested other information six months earlier from the San Diego-based biotechnology company.

The requests for information have delayed approval for Symlin, which is designed to treat Type II diabetes, the most common form of diabetes which typically develops in adulthood and is closely linked to obesity.
Early this year, Amylin withdrew its marketing application for Symlin from Swiss regulators, after authorities there said the medicine could not be approved.

Swiss authorities cited concerns about whether the benefits of Symlin outweighed risks such as nausea and hypoglycemia — a serious drop in blood sugar levels that can cause fainting and confusion.
In June, Amylin and its marketing partner, Eli Lilly and Co. the FDA to approve another diabetes drug, called Exenatide, which industry analysts said has a far better commercial potential than Symlin.
Exenatide, made from the saliva of a desert lizard, is the first in a new class of medicines known as incretin mimetics.
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FACT: Researchers at the University of Kansas have shown that a cholesterol-lowering herbal drug guggulsterone, the active ingredient in gugulipid, also produces an unwanted side effect: It accelerates the breakdown of prescription drugs that fight the effects of AIDS and cancer. Experiments showed that it turns on a cell receptor called PXR. This, in turn, triggers a liver enzyme that breaks down almost 60 percent of the prescription drugs on the market. Journal of Pharmacology and Experimental Therapeutics.