FDA OKs Secretin in Pancreas Care

Doctors struggling to diagnose pancreatic illnesses will soon get a new aid. The government approved the first synthetic version of the hormone secretin on Friday.

Secretin is a digestive enzyme best known as a controversial, unproved treatment for autism. But the substance, derived from pig intestines, long was used to help diagnose serious pancreatic dysfunction or a pancreatic tumor called a gastrinoma. Then in 1999, the sole secretin producer quit selling; dwindling leftover supplies have been available since then only in clinical trials.

The Food and Drug Administration gave approval Friday to SecreFlo, the first synthetic secretin, for pancreatic diagnosis. It was classified an orphan product because only about 15,000 patients a year may need it--but for them, it is an important diagnostic tool.

“Secretin is still the best way” to diagnose pancreas illnesses, said Dr. Lilia Talarico, FDA’s gastrointestinal drugs chief.

The drug’s effect on gastrointestinal secretions helps diagnose pancreatic dysfunction, where thick mucus prevents essential enzymes from breaking down food. Secretin’s effects on another hormone in the bloodstream can help doctors spot a gastrinoma earlier than with other tests.

A synthetic version carries less of a risk of allergic reactions, Talarico said.

Also, the new secretin is 99.6% pure, while the pig-derived product was only 60% pure, said Edward D. Purich of ChiRhoClin Inc., a five-person company in Silver Spring, Md., that came up with the synthetic idea and hired a mix of other companies to help make it reality.

The drug will be marketed by RepliGen Corp., which is conducting clinical trials of secretin and autism.

A price has not yet been set, Purich said.

The first batches should begin selling this summer, although he said doctors can contact ChiRhoClin to get doses sooner for possible gastrinoma patients.