Tiny trial suffices for FDA approval of scorpion sting antidote

Arizona is ground zero in the U.S. when it comes to scorpion bites. The state accounts for the lion's share of some 17,000 reported stings a year, which can have a shattering effect on children and even some adults. But thanks to the work of a group of researchers at the University of Arizona, the FDA has now approved the country's first antidote for scorpion stings. And they pushed through a priority review on the back of a tiny U.S. clinical trial.

That's good news for Tennessee-based Rare Disease Therapeutics, which holds the U.S. license on Anascorp. The antivenom was originally developed in Mexico, where scorpion stings are common, using the plasma of horses immunized with scorpion venom and vaccinated against human viruses. And now it can be used to treat the 17,000 stings reported each year, including the 11,000 coming straight from Arizona.

The university researchers found that the antivenom has a tonic effect on children bitten by scorpions. Of the 15 children involved in the Arizona study--all of whom were thrashing their limbs or experiencing abnormal eye movements and other telltale symptoms of a scorpion bite--8 were given the antivenom. The rest were given a placebo. All of the children in the drug arm were successfully treated, with the symptoms disappearing inside of four hours. The placebo arm experienced symptoms for much longer times and required extended hospitalization.

"We at the APDIC and University of Arizona College of Pharmacy are very excited (about Anascorp's approval). I am proud of the expertise of the pharmacists and physicians working at the APDIC who helped make this research possible," says Keith Boesen, managing director of the Arizona Poison and Drug Information Center.

- check out the release from the FDA
- here's the story from the Wall Street Journal

Suggested Articles

Reata’s bardoxolone improved kidney function in a phase 3 trial of patients with a rare form of chronic kidney disease.

The suit alleges the FDA imposed the hold “without notice or explanation” and has since “rebuffed” Regenxbio’s repeated requests for an explanation.

Bolt Biotherapeutics presented positive results from animal trials of its lead drug, a tumor-targeting antibody connected to an immune stimulator.