Anascorp, orphan drug for scorpion stings, receives FDA approval

Anascorp, the first explicit treatment for Centruroides scorpion stings, has received FDA approval for use in the United States.

The state of Arizona in the US is quite a popular habitat for venomous scorpions. Infants and children are their most common victims, and these severe stings cause shortness of breath, fluid in the lungs, breathing problems, excess salivation, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Fatality is seen in some untreated cases.

Director of the FDA’s Center for Biologics Evaluation and Research, Karen Midthun, MD, said: “This product provides a new treatment for children and adults and is designed specifically for scorpion stings. Scorpion stings can be life-threatening, especially in infants and children.”

The plasma of horses immunized with scorpion venom is used to produce Anascorp, a Centruroides (Scorpion) Immune F(ab’)2 (Equine) Injection. Individuals sensitive to horse proteins may display early or delayed allergic reactions with Anascorp treatment. This scorpion sting treatment is manufactured by taking measures to reduce the risk of allergic reactions and decrease the chances of viral transmissions through the plasma.

Results obtained from a randomized, double-blind, placebo-controlled trial in 15 children with scorpion stings showing neurological signs were used to establish the efficacy of Anascorp. Compared to only one participant receiving placebo, a total of 8 subjects receiving Anascorp completely recovered from the neurological signs within four hours of treatment. Vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain were amongst the most commonly observed side effects. Both the open-label and blinded studies used safety and efficacy data from 1,534 patients.

Designated as an Orphan drug by FDA, Anascorp received priority review by the agency. It is manufactured by Instituto Bioclon, S.A. de C.V., of Tlalpan, Mexico, D.F, distributed by Accredo Health Group Inc., Memphis, TN, and licensed to Rare Disease Therapeutics Inc., Franklin, TN.