WASHINGTON-The FDA has approved Symlin (pramlintide acetate), as the first-in-a new class of injectable medicines for adults with type 1 and type 2 diabetes.
The drug is to be used in conjunction with insulin for patients who have difficulty maintaining glycemic control.
Made by Amylin Pharmaceuticals of San Diego, Calif., the drug is a synthetic analog of amylin. Amylin (also known as islet amyloid polypeptide) is a peptide hormone secreted by pancreatic beta cells in conjunction with insulin in response to nutrient stimuli. Symlin is an analog of human amylin that slows gastric emptying and reduces postprandial rises in blood glucose concentrations.
Action Points
- Patients with either type 1 or type 2 diabetes who have difficulty maintaining glycemic control - especially postprandial control - should be considered for a trial of Symlin. The FDA notes that Symlin should only be used by patients who understand how to modify therapy based upon frequent blood sugar measurements and will carefully follow instructions.
- The drug has not been evaluated in a pediatric population.
- Hypoglycemia is a risk with Symlin, so patients who cannot tell when their blood sugar is low or those with slow stomach emptying are not good candidates for Symlin therapy.
Symlin will be the only therapy for the treatment of type 1 diabetes other than insulin. Patients with type 2 diabetes already have several other types of oral therapies available.
Symlin is a self-administered injection that is given prior to meals to help postprandial glycemic control, which would promote fewer fluctuations in blood glucose throughout the day. In safety and efficacy studies, patients using Symlin achieved better long term HbAIC than patients using insulin alone. Moreover, patients used less mealtime insulin and had a reduction in body weight compared with patients using insulin alone.
The FDA notes that Symlin should only be used by patients who are "already using their insulin as prescribed, but still need better blood sugar control; 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 bedtime; and understand how to adjust Symlin and insulin doses."
The FDA warns that patients who cannot tell when their blood sugar is low, as well as those who have gastroparesis, or who are allergic to Symlin, metacresol, D-mannitol, acetic acid or sodium acetate should not use Symlin.
The most frequent side effects are nausea, vomiting, abdominal pain, headache, fatigue and dizziness. Symlin has not been evaluated in children.
Primary Source
FDA Talk Paper