PHOENIX, Dec. 06, 2017 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”), announced today that its New Drug Application (NDA) for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the U.S. Food and Drug Administration (FDA).
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of July 28, 2018 to complete its review of this NDA, which was based primarily on a pivotal trial that met its primary efficacy endpoint and several pharmacokinetics studies.
To expand the duration of exposure for this investigation new drug candidate, INSYS also recently completed a seven-day safety and tolerability study with 100 patients. Data from this study will be submitted to the FDA in the first quarter of 2018, augmenting the NDA package, and may impact the PDUFA date.
“We look forward to working with the FDA in 2018 to add our buprenorphine sublingual spray to the range of treatment options available to physicians whose patients suffer from moderate-to-severe acute pain,” said Steve Sherman, senior vice president of regulatory affairs at INSYS. “We believe that this novel formulation and delivery method of buprenorphine holds great promise as an alternative to traditional opioids.”
INSYS anticipates that the potential benefits of buprenorphine include a ceiling effect for respiratory depression and, compared to other opioids frequently used in this indication, less abuse potential, less cognitive impairment and less constipation.
“To support the progress of our product pipeline through the regulatory path, we set a goal this year to file one NDA per year for the next five years,” said Saeed Motahari, president and chief executive of INSYS. “With the FDA’s acceptance of our NDA for buprenorphine sublingual spray, we are off to a good start.”
In addition to buprenorphine sublingual spray, INSYS is also developing treatments for a variety of conditions other than pain, including synthetic cannabidiol (CBD) for two types of pediatric epilepsy and Prader-Willi syndrome; dronabinol for anorexia-associated weight loss in cancer and agitation in Alzheimer’s disease; buprenorphine/naloxone sublingual spray for opioid dependence; naloxone nasal spray for opioid overdose; epinephrine nasal spray for anaphylaxis; and rizatriptan nasal spray for migraine.
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.
This news release contains forward-looking statements including regarding our belief that (i) this novel formulation and delivery method of buprenorphine holds great promise as an alternative to traditional opioids and (ii) the potential benefits of buprenorphine include a ceiling effect for respiratory depression and, compared to other opioids frequently used in this indication, less abuse potential, less cognitive impairment and less constipation. 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.