FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Epinephrine Nasal Spray as Investigational Treatment for Anaphylaxis
INSYS THERAPEUTICS (INSY)
Last insys therapeutics earnings: 11/5 04:16 pm
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Source: GlobeNewswire
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.” In a previous clinical trial, the intranasal epinephrine product candidate from INSYS showed promise as a potential needle-
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