FDA-approved cyanide antidote launches

An antidote indicated for the treatment of acute cyanide poisoning judged to be life-threatening has launched.

Co-packaged sodium nitrite injection, USP and sodium thiosulfate injection, USP antidote (Nithiodote, Hope Pharmaceuticals) was granted priority review and was subsequently approved by FDA earlier this year for the treatment in children and adults. It is the only product containing sodium nitrite or sodium thiosulfate that has been approved by FDA.

The introduction of new antidotes for the treatment of chemical threats can enhance public safety and homeland security, a company press release stated.

Cyanide blocks the use of oxygen by cells. Organs that routinely use large quantities of oxygen to function, such as the brain and the heart, sustain irreversible injury if deprived of oxygen for as little as 4 minutes. If not treated and resolved quickly, cyanide poisoning can be lethal.

Lethal exposures to cyanide generally result from industrial accidents, suicides, and terrorist attacks. Examples include the use of cyanide in the 1979 mass murder in Jonestown, Guyana; the 1982 lacing of over-the-counter medicine in Chicago; and the 1995 attack of a subway system in Tokyo.

Nithiodote consists of 2 medications that are packaged together, sodium nitrite injection and sodium thiosulfate injection. Each of these medications has a different action against cyanide. Sodium nitrite helps to remove cyanide from cells and thereby restores cellular use of oxygen. Sodium thiosulfate converts cyanide to a less toxic molecule that can be readily excreted in the urine. Compared to the individual effects of each, the combination significantly enhances the detoxification of cyanide effects in the body.

“Every second is huge with the treatment of cyanide poisoning,” said Craig Sherman, MD, medical director of Hope Pharmaceuticals, in a press release. “Unlike other medications, Nithiodote is ready stat, since sodium nitrite and sodium thiosulfate are sterile solutions that can be administered immediately without delay.”

Sodium nitrite can be infused in as little as 2 minutes, and sodium thiosulfate can be infused immediately afterward.

For prescribing or ordering information, go to www.hopepharm.com.