Synthetic Human Secretin Product Approved by FDA
The Food and Drug Administration (FDA) on Friday approved the marketing of synthetic human secretin injection by ChiRhoClin Inc.
ChiRhoClin Medical Director Seymour Fein said the new diagnostic product's indications for use are the same as for the company's synthetic porcine secretin injection:
- Stimulation of pancreatic secretions to help determine whether there is a dysfunction in the gland's ability to secrete digestive enzymes,
- Stimulation of pancreatic secretions to aid, during endoscopic retrograde cholangiopancreatography, in the identification of the hepatopancreatic ampulla (a dilatation formed by junction of the pancreatic ducts and the common bile duct) and accessory structures, and
- Stimulation of gastrin secretion to aid in the detection of a gastrin-secreting tumor, considered the usual cause of Zollinger-Ellison syndrome.
Fein said the new product's sole contraindication—use during an episode of acute pancreatitis—is a carryover from the labeling for the original, now-discontinued secretin product from Ferring Pharmaceuticals.
The recommended dosages of synthetic human secretin injection are the same as for the synthetic porcine product, Fein said, since "potency seems to be essentially the same." As with the porcine product, a test dose of the new product is recommended, although he said, to his knowledge, an allergic reaction has not occurred during use of the older ChiRhoClin secretin product, which Repligen Corp. markets as Secreflo.
The company announced in October 2005 that its secretin product is commercially available and has the brand name ChiRhoStim.
Product manager Skip Purich said ChiRhoClin is still working with FDA to finalize an acceptable brand name for the new product, which will be sold in vials containing 16 micrograms of lyophilized drug. At this time, he said, the company has not determined when it will have the product available for purchase.
Fein said the product's initial FDA-approved labeling calls for storage of the unused vials at -20 degress C.