INSYS Therapeutics Starts Proof-of-Concept Study of Epinephrine Nasal Spray for Anaphylaxis

PHOENIX, Dec. 07, 2017 -- INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”), announced today that it has started a proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis, or severe allergic reaction, with the enrollment of the first patient.

This Phase 1 clinical trial is designed to establish whether intranasal administration of epinephrine is bioequivalent to the standard method of delivering the drug, which is through intramuscular injection (typically with Mylan’s EpiPen^®).

“We believe that delivering epinephrine through the mucosa of the nasal passages has the potential to compare favorably to intramuscular injection, both clinically and practically,” said Steve Sherman, senior vice president of regulatory affairs at INSYS Therapeutics. “This study will test that hypothesis.”

The study envisions enrolling a total of 60 adult patients (18–45 years of age) in five 12-patient cohorts at a single clinical site. To qualify for enrollment, all study patients will be confirmed to be healthy subjects with a history of seasonal allergies; after enrollment, they will be exposed to an intranasal allergen at specific timepoints as part of the protocol. Other inclusion and exclusion criteria apply.

The study has three primary objectives: first, to compare the bioavailability of aqueous formulations to that of hydro-alcoholic formulations of the company’s proprietary epinephrine nasal spray at two doses (3mg and 6mg); second, to compare the bioavailability of both formulations (aqueous and hydro-alcoholic) to that of the standard intramuscular injection — specifically, EpiPen^® (0.30mg); and third, to evaluate the effect of an intranasal allergen challenge on the bioavailability of both intranasal epinephrine spray formulations at both doses. Secondarily, the study will evaluate the safety and tolerability of both formulations at both doses.

INSYS expects enrollment in the study to be complete in the first quarter of 2018, with initial results for all enrolled patients available by February. Based on the results, the company will decide whether to proceed with additional trial phases as part of its clinical development program.

In addition to epinephrine nasal spray for anaphylaxis, INSYS is also developing treatments for a variety of other conditions, including synthetic cannabidiol (CBD) for two types of pediatric epilepsy and Prader-Willi syndrome, a rare and complex genetic disorder characterized by insatiable appetite in childhood that often leads to obesity and type 2 diabetes; dronabinol for anorexia-associated weight loss in cancer and agitation in Alzheimer’s disease; buprenorphine sublingual spray for moderate-to-severe acute pain; naloxone nasal spray for opioid overdose; buprenorphine/naloxone sublingual spray for opioid dependence; and rizatriptan nasal spray for migraine.

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 intending to address unmet medical needs and the clinical shortcomings of existing commercial products.

Forward-Looking Statements 
This news release contains forward-looking statements including regarding (i) our belief that delivering epinephrine through the mucosa of the nasal passages has the potential to compare favorably to intramuscular injection and (ii) our expectations regarding enrollment in the aforementioned study. 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, 2016 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.