ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue™ Therapy for the Treatment of Local Anesthetic Systemic Toxicity
CHICAGO–(BUSINESS WIRE)–ResQ Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for LipidRescue™ Therapy (LRT) for the indication of local anesthetic systemic toxicity (LAST). ResQ Pharma is a biopharmaceutical company focused on ensuring reliable global access to (LRT), a treatment for various drug overdoses and poisonings.
In addition, the company recently received an Advice Letter from the FDA guiding the company to prepare a new drug application (NDA) based on the existing literature, case reports and new manufacturing specifics via the 505(b)2 pathway (“paper NDA”). The company is on track to file the NDA in the first half of 2018. Given this accelerated path to potential regulatory approval, the company is currently soliciting commercialization partners. ResQ Pharma’s CEO, Paul Burton, will be attending BIO 2017 in San Diego June 19th thru 23rd.
According to the Centers for Disease Control and Prevention (CDC), 52,404 people died in 2015 from drug overdoses in the US alone. Approximately half of those, over 25,000, involved non-opioid drugs.
“ResQ Pharma is energized about the opportunity to better address the global problem of severe drug overdoses by commercializing a life-saving therapy for this category of overdoses,” said Paul Burton, CEO, ResQ Pharma. “Currently, there is no FDA approved treatment for LAST and other severe non-opioid, lipophilic drug overdoses.”
About LipidRescueTM Therapy (LRT)
ResQ Pharma’s lead product candidate is LRT, which refers to the administration of a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive doses of certain lipophilic drugs. It is already the opinion of the American Heart Association and American College of Medical Toxicology that where there is serious hemodynamic instability from local anesthetic drugs with high lipid solubility, LRT is a reasonable consideration for therapy, even if the patient is not in cardiac arrest.
About ResQ Pharma
ResQ Pharma, Inc., is a biopharmaceutical company created to ensure access to reliable, global use of LRT, a treatment for various lipophilic drug overdoses and poisonings. For more information on ResQ Pharma, please visit www.LipidRescue.com. We are members of iBIO’s PROPEL, EnterpriseWorks Chicago, Chicago Founders Circle, The BUNKER and MATTER! We are also a Qualified New Business Venture for the Illinois Investment Tax Credit Program. For more information, please visit www.ResQPharma.com.
About Paul Burton, J.D., M.B.A.
Mr. Paul Burton has served as the CEO of ResQ Pharma since July 2015. He is a former investment banker having started his career as an investment banking associate with Salomon Brothers/Salomon Smith Barney in New York City in 1998 upon completion of both law school and business school at the University of Illinois at Urbana-Champaign. More recently he has worked with several entrepreneurial ventures in healthcare. Mr. Burton is also a former U.S. Regular Army Commissioned Officer (Infantry).
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “believes,” “potential,” “proposed,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, analyses or current expectations concerning, among other things: our expectations regarding the clinical effectiveness and safety of our product candidates and results of studies; and the timing of and our ability to obtain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing studies for LRT. Any forward-looking statements in this press release speak only as of the date of this press release.