Is this the answer to the EpiPen price hike?
Last month, the first patient was enrolled in a clinical trial that will study the use of an epinephrine nasal spray for the treatment of anaphylaxis, a life-threatening allergic reaction.
The study by INSYS Therapeutics will compare intranasal epinephrine administration with the more traditional delivery method, intermuscular injection, like with Mylan’s EpiPen. It will also examine the bioavailability of the solutions proposed with the product and measure the safety and tolerability of these formulations.
“We believe that delivering epinephrine through the mucosa of the nasal passages has the potential to compare favorably to intramuscular injection, both clinically and practically,” said Steve Sherman, senior vice president of regulatory affairs at INSYS Therapeutics, in a news release. “This study will test that hypothesis.”
INSYS expects enrollment in the study to be complete in the first quarter of 2018, with initial results for all enrolled patients available by February. Based on the results, the company will decide whether to proceed with additional trial phases as part of its clinical development program.
“Speed of delivery and magnitude of effect are the most important factors in treating anaphylaxis,” says Dr. Marlito Favila, urgent care physician with Advocate BroMenn Medical Center in Normal, Ill. “It will be interesting to see if their delivery system can bring the same concentration, onset and ultimately, effect.”
About the Author
Lynn Hutley, health enews contributor, is coordinator of public affairs and marketing at Advocate BroMenn Medical Center and Advocate Eureka Hospital in central Illinois. Having grown up in a family-owned drug store, it is no surprise that Lynn has spent almost 18 years working in the health care industry. She has a degree in human resources management from Illinois State University and is always ready to tackle Trivia Night.