INSYS Therapeutics, Inc. (INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced the results of a dose-finding pharmacokinetic (PK) study (INS015-18-124) of its epinephrine nasal spray. These results identified a dose that showed a PK profile similar to that of intramuscular injection of EpiPen® (0.3 mg) and Adrenalin® (0.5 mg), both of which are treatments for anaphylaxis, an acute, life-threatening allergic reaction.
The dose-finding PK study, INS015-18-124, was a single-dose, open-label, randomized, four-treatment, four-way crossover study to assess the pharmacokinetics of two doses of epinephrine nasal spray and two reference products, EpiPen® (0.3 mg) and Adrenalin®(0.5 mg) in 49 healthy volunteers.
Additionally, as reported on Jun. 14, 2018, the proof-of-concept PK study (INS015-17-112), demonstrated rapid drug absorption through the nasal mucosa and similar bioavailability to that of an intramuscular injection of EpiPen® (0.3mg) in nasal allergen challenged subjects.
“The results of our proof-of-concept (INS015-17-112) and dose-finding (INS015-18-124) studies confirmed that INSYS’ novel, proprietary formulation of epinephrine delivered intranasally potentially offers a viable, attractive alternative and non-invasive delivery option to the currently marketed products,” said Dr. Venkat Goskonda, senior vice president of research and development at INSYS Therapeutics. “These results enable us to select an appropriate dose for advancing to the next stage of clinical development. We look forward to working with the FDA to bring a new treatment option for allergy sufferers who experience anaphylaxis.”
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.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation on Aug. 30, 2018 to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.
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.
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.