FDA Approves New Diabetes Drug Symlin
Injectable Drug Helps Control Blood Sugar in Type 1 and Type 2 Diabetes
The FDA has approved a drug called Symlin to help control blood sugar in
people with type 1 and type 2 diabetes who do not achieve good blood sugar
control with insulin therapy.
Symlin, an injectable drug, is a manufactured version of human amylin, a
hormone secreted along with insulin. Symlin is given at mealtimes and will not
replace insulin. Instead, it is only to be used with insulin to help lower
blood sugar during the three hours after meals, says the FDA.
Symlin is also not intended for everyone with diabetes, says the web site of
the drug's maker. It's only for patients who are already using medicine as
advised but still need more help to control blood sugar.
"Symlin is to be used in addition to insulin therapy in patients who
cannot achieve adequate control of their blood sugars on intensive insulin
therapy alone," says an FDA statement.
Symlin is made by Amylin, a San Diego biotech company. In January 2004,
Amylin withdrew its application to sell Symlin in Switzerland when questions
arose about side effects including nausea and hypoglycemia (low blood sugar).
Both of those side effects are noted on the drug's labeling and medication
Amylin has another diabetes drug, Exenatide, awaiting FDA approval. Late
last year, John Buse, MD, PhD, told WebMD he expected Exenatide to be approved
for type 2 diabetes. Buse directs the Diabetes Care Center at the University of
North Carolina's medical school.
"So-called 'tight' control of blood sugar is desirable in all diabetes
patients," says the FDA. Closely controlling blood sugar can help reduce
risks of long-term problems tied to diabetes, including blindness, kidney
disease, and heart disease.
Besides insulin, Symlin will be the only therapy for treating type 1
diabetes. Several oral medicines are already available for people with type 2
Candidates for Symlin
Symlin has not been evaluated for use by children. The FDA says the drug
should only be used if patients:
- Are already using their insulin as prescribed but still need better blood
- Will follow their doctor's instructions exactly
- Will follow up with their doctor often
- Will test their blood sugar levels before and after every meal, and at
- Understand how to adjust Symlin and insulin doses
Symlin should not be used if patients:
- Can't tell when their blood sugar is low
- Have a complication called gastroparesis, which slows the absorption of
food and makes blood sugar control erratic
- Are allergic to pramlinitide acetate, metacresol, D-mannitol, acetic acid,
or sodium acetate
Symlin's safety and effectiveness were studied in about 5,000 patients.
Overall, the drug was associated with improvements in blood sugar control and
weight loss. Benefits were seen with both types of diabetes, says the FDA.