INSY Insys Therapeutics, Inc.

INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, presented a poster of its initial pharmacokinetic (PK) study of comparative bioavailability of epinephrine nasal spray and EpiPen® in adults with seasonal allergies at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Francisco, California on Feb. 24, 2019.

The results presented at the meeting were from the initial PK study with a total of 60 adults with seasonal allergies. The objective of the study was to compare bioavailability of two proprietary nasal formulations of epinephrine with EpiPen® 0.3 mg in subjects with seasonal allergies with and without allergen challenge. Safety assessments were conducted throughout the study which included physical and nasal exams, adverse event collection, vital signs monitoring, ECG evaluation, and clinical laboratory and olfactory testing.  The study results demonstrated that both formulations of epinephrine nasal spray are absorbed rapidly in subjects with and without allergen challenge. All adverse events reported were either mild or moderate in severity. The presented poster may be viewed on the INSYS Therapeutics corporate website.

“These results presented to the scientific community further support the potential for a needleless alternative to the current standard of care and further validates the viability of an intranasal delivery system for epinephrine for the treatment of allergic reactions including anaphylaxis,” said Dr. Venkat Goskonda, senior vice president of research and development at INSYS Therapeutics. “We look forward to continuing to work with the FDA to bring this new option to the patient community.”

The validity of INSYS’ formulation as an alternative to the current standard of care for the treatment of allergic reactions including anaphylaxis was further supported by the Company’s dose finding PK study conducted in Jan. 2019.

About INSYS

INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, and other disease areas with a significant unmet need.

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Forward-Looking Statements 

This news release contains forward-looking statements based on management’s expectations and assumptions as of the date of this news release. Actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risks described in our filings with the United States Securities and Exchange Commission, including those discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

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