Insys Announces NDA Acceptance of its Fentanyl SL Spray

PHOENIX--(BUSINESS WIRE)-- Insys Therapeutics, Inc. (formerly NeoPharm, Inc.) (Other OTC:NEOL.PK) today announced that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Fentanyl SL Spray. The FDA will notify Insys of its PDUFA date in the 74-day letter which is expected in the upcoming weeks.

“We are excited to have the FDA accept our filing, and we look forward to building a commercial infrastructure to launch this product for patients suffering from breakthrough cancer pain,” said Insys CEO Michael Babich. “The proprietary sublingual delivery system will provide us an opportunity to deliver pain relief to cancer patients who suffer from excruciating acute pain episodes that overcome the analgesia of chronic opioid medications.”

About Insys Therapeutics, Inc.

Insys Therapeutics, Inc., based in Phoenix, Arizona, is developing and seeking to commercialize innovative pharmaceutical products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. Insys utilizes proprietary technologies to develop product candidates that address the clinical shortcomings of existing commercial products. Additional information can be obtained by visiting the Insys Therapeutics web site at

Forward Looking Statements

This press release contains "forward-looking statements" that may be identified by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," “look forward to” and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, statements relating to the status of Insys’ drug development programs, the prospects, potential regulatory approval and potential commercialization of Fentanyl SL Spray, Insys’ plans to build a sales force, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to Insys’ ability to obtain financing to fund its operations, difficulties or delays in the development, receipt of regulatory approval, production, and marketing of Insys’ product candidates, Insys’ ability to hire, train and successfully deploy a sales force, unexpected adverse side effects or inadequate therapeutic efficacy of Insys’ product candidates, and the uncertainty of patent protection for Insys’ intellectual property or trade secrets. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned in this press release. For the foregoing reasons, you should not rely on these forward-looking statements as a prediction of actual future results.


Insys Therapeutics, Inc.
Michael L. Babich
[email protected]

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