If approved, the kit will treat LAST with the rapid and accurate infusion of a clinically-recommended dose of lipid emulsion that has been shown to safely and effectively counteract toxicity and save patient lives. LAST is an uncommon but potentially fatal event that occurs during the use of local anesthetics.
The assignment of a PDUFA date is an important milestone for every new drug application as it indicates that the application is sufficiently complete to permit a substantive review and provides guidance on when the review should be completed.
Dr. Guy Weinberg, Founder and President of ResQ Pharma and the inventor of LipidRescue Therapy (LRT) said: "Since discovering more than 25 years ago that lipid emulsion infusion could reverse catastrophic reactions to local anesthetics, I have looked forward to the day that this novel therapy would become a widely available, standardized treatment for a dangerous and potentially fatal condition. As we await potential FDA review and approval, and prepare to launch the LipidRescue Kit, I'm very thankful to the many physicians, researchers, advisors and others who have been allies to ResQ Pharma over the years."
Mukesh Kumar of FDAMap in Washington DC consulted on the preparation of the New Drug Application (NDA) for ResQ Pharma and serves as ResQ Pharma's Director of Regulatory Affairs. Michael Gaba, Vice Chair of Polsinelli's FDA practice group, serves as ResQ Pharma's outside FDA counsel.
About LAST:
LAST is a life-threatening event that can occur whenever local anesthetics are used in any of a variety of healthcare settings. Commonly used local anesthetics include lidocaine, bupivacaine, and ropivacaine. Typical early symptoms of LAST include altered mental status (e.g. agitation, confusion, dysphoria) and cardiac instability ( e.g., arrhythmia, hypotension) that can progress to seizures, coma, respiratory or cardiac arrest, and even death.
About LipidRescue™:
LipidRescue is a soybean oil emulsion that mitigates the toxic effects of local anesthetic overdose. Infusing such an emulsion agrees with guidance for treating LAST published by several professional societies; extensive preclinical literature and more than a hundred published, peer-reviewed case reports support the efficacy and safety of this method. Toxicology studies indicate that LipidRescue is safe with minimal adverse reactions when given according to instructions and dose limits.
About ResQ Pharma:
ResQ Pharma, Inc., is a biopharmaceutical company seeking to ensure reliable, global use of LRT, a standard of care for LAST and a potential treatment for various other lipophilic drug overdoses and poisonings. The company was founded by Dr. Guy Weinberg to commercialize the findings of his research on the mechanisms and treatment of local anesthetic toxicity. Dr. Weinberg is a Professor of Anesthesiology at the University of Illinois College of Medicine. He has been honored with several prestigious awards by the anesthesia profession and is a frequent speaker and guest lecturer around the world. The privately-held company is based in Chicago, Illinois.
For more information please visit www.ResQPharma.com.
