EMD Pharmaceuticals Files Application for Drug To Fight Cyanide Poisoning
Posted June 20, 2006 2:38 a.m. EDT
DURHAM, N.C. — EMD Pharmaceuticals
has filed a new drug application with the Food and Drug Administration for a drug to fight cyanide poisoning.
The drug is called Cyanokit. It currently is sold in France.
EMD Pharmaceuticals is a U.S. subsidiary of drug giant Merck and is based in Durham. The NDA is the first for the company.
The FDA has already granted Cyanokit fast track designation, which is designed to help bring drugs to market for serious or life-threatening conditions with unmet medical needs.
"As our first NDA filing, this submission marks an important milestone for both the product and our company," said Nancy Wysenski, president of EMD Pharmaceuticals. "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."
Cynaokit has already been used in France for a decade to treat cyanide poisoning resulting from smoke inhalation, ingestion and other causes.
"Timing is critical when cyanide poisoning is suspected and having an antidote available at the scene of the incident can be the difference between life and death," said Keith Steward, EMD's vice president of Medical Affairs. "Cyanokit has many potential applications, including fires, industrial accidents or other incidents in which individuals have inhaled or ingested cyanide. In addition, Cyanokit could also be used to improve national preparedness for acts of chemical terrorism."
EMD is focused on cancer treatment and central nervous system disorders as well as cyanide poisoning.