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EMD Pharmaceuticals files NDA for cyanide poisoning treatment
By Elaine Rigoli
Tampa, Fla., June 20 - EMD Pharmaceuticals, Inc. said it has filed a New Drug Application with the Food and Drug Administration for Cyanokit (hydroxocobalamin), in development for the treatment of known or suspected cyanide poisoning.
The FDA has previously granted Cyanokit fast-track designation, which is intended to facilitate the development of new therapeutic medicines for the treatment of serious or life-threatening conditions with unmet medical needs.
EMD said a common and often unrecognized source of cyanide exposure occurs during a fire. Cyanide may be produced by the pyrolysis (incomplete burning) of common synthetic or plastic materials as well as from natural materials such as wood, paper and silk.
The company said cyanide is increasingly recognized to be as common and dangerous as carbon monoxide as a fire smoke toxicant.
"With no new product approved to treat cyanide poisoning for several decades, this submission underscores our commitment to provide a new treatment for cyanide poisoning in the United States, especially one that would be available to treat smoke inhalation in a pre-hospital as well as a hospital setting," EMD president Nancy J. Wysenski said in a news release.
The Cyanokit filing includes data from animal and human studies that document the safety and efficacy of the product, including information from actual patient case studies of smoke-inhalation victims treated with Cyanokit in France for suspected cyanide poisoning, the release said.
A U.S. subsidiary of Merck KGaA of Darmstadt, Germany, EMD Pharmaceuticals is a specialty pharmaceutical company located in Durham, N.C.
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