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FDA Grants INSYS Therapeutics’ Fast Track Designation for Epinephrine Nasal Spray

Arizona-based specialty pharmaceutical company INSYS Therapeutics saw its shares explode after announcing that the Food and Drug Administration has granted its epinephrine nasal spray fast track designation.

The FDA has granted the company’s epinephrine nasal spray fast track designation as an investigational treatment for anaphylaxis.

Anaphylaxis is a severe, potentially life-threatening allergic reaction. It can occur within seconds or minutes of exposure to something you’re allergic to.

INSYS has said that the previous clinical trial showed promise as a potential “needle-free, non-invasive and easy-to-use alternative” to intramuscular injection.

“The receipt of Fast Track designation represents a significant milestone for Insys and our clinical development of this novel drug-device combination,” said the company’s senior vice president of regulatory affairs, Steve Sherman.

He added, “We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible.”

According to the Mayo Clinic, there are more than 200,000 cases of anaphylaxis each year in the United States.

The World Allergy Organization estimates that up to two percent of the global population will experience anaphylaxis during their lifetime.

With the fast track designation, INSYS Therapeutics will be able to navigate the FDA approval process more easily and efficiently.

If approved, the company’s epinephrine spray could come to market a lot faster than other companies going through the normal process.

The company reported second quarter earnings results on Wednesday, August 8th, revealing a loss of 33 cents for earnings per share, missing analysts’ consensus estimates of a loss of 16 cents.

CEO Saeed Motahari said during the earnings call, “We began 2018 with a commitment to continue to executing our strategic plan to transform Insys into a leader in the pharmaceutical cannabinoids and spray technology. And the second quarter exemplifies that commitment. From the recent progress we have driven across our pipeline to the incrementally positive development for both of our marketed products, I am pleased with our efforts to strengthen the foundation and advance the shift from opioids to cannabinoids and spray technology, nonetheless there is some work to be done.”

“The progress we have made this quarter in our pipeline some encouraging results from the proof of concept study of our epinephrine nasal spray to advancing the size of CBD, by expanding our partnership with the UC San Diego Center for Medicinal Cannabis Research and exploring collaboration with NIH, reflect the talented R&D team we have here at Insys.”

“Additionally, the FDA recently approved the first drug comprised on a active ingredient drive from the Cannabis plan. We believe our cannabinoids platform is truly unique, as we are focused on different indication using our synthetically dry and 99.5% pure CBD oral solutions.”

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