Insys Therapeutics Reports Phase 3 Trial of Sublingual Buprenorphine Spray Met Primary Endpoint in Patients with Moderate-to-Severe Postoperative Pain after Bunionectomy

PHOENIX, Aug. 24, 2016 -- Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") today reported that the Phase 3 trial for the Buprenorphine Sublingual Spray met its primary endpoint. 

The trial  was a multicenter, randomized, double-blind, multiple-dose, placebo-controlled study evaluating the efficacy and safety of three dosing regimens of Buprenorphine Sublingual Spray (0.5 mg three times daily (“tid”), 0.25 mg tid, or 0.125 mg tid), and/or matching placebo in subjects with moderate to severe postoperative pain after bunionectomy.  322 subjects were randomized.  As agreed with the U.S. Food and Drug Administration (“FDA”), the primary efficacy endpoint in this study was the Summed Pain Intensity Difference relative to baseline over a period of 48 hours (SPID-48).  The patient assessment of pain intensity utilized a numeric pain scale (11-point scale with 0 = no pain to 10 = worst possible pain).

The primary efficacy endpoint was statistically significant at all doses studied.  The Buprenorphine Sublingual Spray 0.5 mg tid demonstrated the largest reduction in SPID-48 and was statistically significant to placebo (p<0.0001).  The 0.25 mg tid and 0.125 mg tid doses also demonstrated statistically significant reductions in SPID-48 (p = 0.0108 and p = 0.0120, respectively).  All treatments were generally well tolerated. 

“We are pleased with the results of this trial indicating that Buprenorphine Sublingual Spray could be a potentially useful drug for the treatment of moderate to severe pain and provide a valuable treatment option in a variety of clinical settings. We look forward to discussing these results with the FDA by the end of the year and subsequent next steps towards filing a New Drug Application,” said Dr. John Kapoor, Chairman, President and Chief Executive Officer, of Insys Therapeutics, Inc.

For more information about the trial, see https://clinicaltrials.gov/ct2/show/NCT02634788?term=NCT02634788&rank=1

About Pharmaceutical Buprenorphine
Insys is developing Buprenorphine Sublingual Spray for sublingual administration as a treatment for moderate to severe pain. The active ingredient is buprenorphine, which is a partial opioid agonist at the mu-opioid receptor and antagonist at the kappa-opioid receptor. Buprenorphine binds to mu-receptors with high affinity but less intrinsic activity compared to full opioid agonists. Because of its partial agonist features, the efficacy and adverse effects of buprenorphine are thought to plateau at higher doses.  Further, buprenorphine dissociates from the mu-receptor very slowly, which likely accounts for its longer duration of action than morphine, and its low level of manifested physical dependence. Actions at kappa-receptors, where buprenorphine is an antagonist, are believed to produce alterations in the perception of pain and the emotional response to pain.

About Moderate to Severe Pain
Millions suffer from acute pain every year and the effects of pain is typically experienced when the free nerve endings of pain receptors are subject to noxious mechanical, thermal, or chemical stimuli. These pain receptors can transmit signals along afferent neurons to the spinal cord and then to the brain. When a person feels pain, any one or more of a number of problems can be associated with this sensation including, but not limited to, reduced function, reduced mobility, complication of sleep patterns, and decreased quality of life. The effects of pain exact a tremendous costs, in rehabilitation, lost worker productivity, as well as the emotional and financial burden it places on patients and their families.

About Insys Therapeutics, Inc.

Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual 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. Insys currently markets one product, SUBSYS^® (fentanyl sublingual spray) but has received approval for the marketing of SYNDROS^TM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule.  Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need.

SUBSYS^® and SYNDROS^TM are trademarks of Insys Development Company, Inc., a subsidiary of Insys Therapeutics, Inc.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding: (i) our expectations that Buprenorphine Sublingual Spray could be a potentially useful drug for the treatment of moderate to severe pain and provide a valuable treatment option in a variety of clinical settings and the potential timeline related to filing an NDA and communicating with the FDA regarding this product candidate, ( (ii) our expectations of addressing unmet needs of patients and the clinical shortcomings of existing commercial products, and (iv) our belief that SYNDROS has distinct advantages over the current formulation of dronabinol in soft gel capsule. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and 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. For a description of these risks facing the company, please see the 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 December 31, 2015 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise these statements, except as may be required by law.

Contact:
Lisa M. Wilson
President, In-Site Communications, Inc. 
212-452-2793