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FDA Accepts New Drug Application for INSYS Therapeutics’ Naloxone Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose

1058 Days ago

PHOENIX, July 03, 2019 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (OTCMKTS: INSYQ), announced today that its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing.  INSYS’ naloxone nasal spray is a single unit dose spray device that delivers 8mg naloxone dose.

“The FDA’s acceptance of the NDA for INSYS’ proprietary formulation of a naloxone nasal spray is an important milestone in battling the U.S. opioid epidemic,” said Dr. Venkat Goskonda, chief scientific officer at INSYS Therapeutics. “We believe our formulation has the potential to be a critical tool in combatting opioid overdose cases. The rapid absorption and significant exposure of the formulation may be useful in opioid overdose, particularly with the rise of synthetic opioid use.”

The Centers of Disease Control and Prevention reported 70,237 drug overdose deaths in the United States in 2017 of which 47,600 involved opioids.


INSYS Therapeutics is a specialty pharmaceutical company using proprietary technology and capabilities to develop and commercialize innovative pharmaceutical products intended to address unmet medical needs and the clinical shortcomings of existing commercial products.

Forward-Looking Statements 

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” “intend” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words.  All statements, other than statements of historical facts, included in this press release that address activities, events or developments that the Company expects, believes, targets or anticipates will or may occur in the future are forward-looking statements. The Company’s actual results may differ materially from those anticipated in these forward-looking statements as a result of certain risks and other factors, which could include the following: risks and uncertainties relating to the Chapter 11 Cases, including but not limited to, the Company’s ability to obtain Court approval with respect to motions in the Chapter 11 Cases, the effects of the Chapter 11 Cases on the Company and on the interests of various constituents, Court rulings in the Chapter 11 Cases and the outcome of the Chapter 11 Cases in general, the length of time the Company will operate under the Chapter 11 Cases, risks associated with third-party motions in the Chapter 11 Cases, the potential adverse effects of the Chapter 11 Cases on the Company’s liquidity or results of operations and increased legal and other professional costs necessary to execute the Company’s reorganization; the effects of disruption from the Chapter 11 Cases making it more difficult to maintain business and operational relationships, to retain key executives and to maintain various licenses and approvals necessary for the Company to conduct its business; uncertainty associated with the Company’s ability to complete the sale of its assets as contemplated by the Chapter 11 Cases; trading price and volatility of the Company’s common stock and well as other risk factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The Company therefore cautions readers against relying on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on the Company’s behalf are expressly qualified in their entirety by the foregoing cautionary statements. All such statements speak only as of the date made, and, except as required by law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.


Investor Relations & Corporate Communications
Jackie Marcus or Chris Hodges
Alpha IR Group


Michael Freitag / Matthew Gross / Andrew Squire
Joele Frank, Wilkinson Brimmer Katcher

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