FDA Grants Fast Track Designation for Epinephrine Nasal Spray as Investigational Treatment for Anaphylaxis


PHOENIX, Aug. 30, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.

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

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In a previous clinical trial, the intranasal epinephrine product candidate from INSYS showed promise as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis. Preliminary results from this pharmacokinetic study involving 60 people with seasonal allergies demonstrated rapid drug absorption with the epinephrine nasal spray and showed that the bioavailability of the company’s novel, proprietary formulation of epinephrine delivered intranasally was similar to that of intramuscular injection with EpiPen® (0.3 mg).

According to the Mayo Clinic, more than 200,000 cases of anaphylaxis occur each year in the United States. The World Allergy Organization estimates that up to two percent of the global population—as many as 150 million people worldwide—will experience anaphylaxis during their lifetime.

Late last year, INSYS also received Fast Track designation for another of its product candidates—specifically, cannabidiol (CBD) oral solution as an investigational treatment for the genetic condition Prader-Willi syndrome. Clinical development for that pipeline product is currently in Phase 2, with enrollment underway. The company’s proprietary formulation of pharmaceutical-grade CBD is also under evaluation for childhood absence epilepsy (Phase 2) and infantile spasms (Phase 3).

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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.

Forward-Looking Statements

This news release contains forward-looking statements including the potential for Fast Track designation to expedite the FDA’s review of our epinephrine product candidate and our belief in this product candidate’s potential to become a needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis. These forward-looking statements are 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, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors 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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