“The receipt of Fast Track designation represents a significant milestone for INSYS and our clinical development of this novel drug-device combination,” said
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
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).
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
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|Joe McGrath||Jackie Marcus or Chris Hodges|
|INSYS Therapeutics||Alpha IR Group|