8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENTREPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 22, 2016

Insys Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-35902	51-0327886
(State or other jurisdiction of incorporation)	(Commission File No.)	(IRS Employer Identification No.)

1333 S. Spectrum Blvd, Suite 100

Chandler, Arizona 85286

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (602) 910-2617

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):

☐     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01        Other Events.

On March 22, 2016, Insys Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has extended, for three months, the Prescription Drug User Fee Act (PDUFA) date for Syndros^TM (dronabinol oral solution) until July 1, 2016.

Insys voluntarily submitted information, which did not involve any clinical data, related to the scheduling of Syndros under the Controlled Substances Act. The FDA determined that this information constituted a major amendment to this New Drug Application and exercised its option to extend the PDUFA date to provide the FDA time to complete its review.

The Company announced the extension of the PDUFA date pursuant to a press release attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01        Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release dated March 22, 2016

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: March 22, 2016	Insys Therapeutics, Inc.
	By:	/s/ Darryl S. Baker
		Darryl S. Baker
		Chief Financial Officer

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release dated March 22, 2016

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE 

Insys Therapeutics, Inc. Announces 3-Month Extension of PDUFA Date for Syndros

PHOENIX, AZ – March 22, 2016 -- Insys Therapeutics, Inc. (NASDAQ: INSY) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for Syndros^TM (dronabinol oral solution) from April 1, 2016 until July 1, 2016.

Insys voluntarily submitted information, which did not involve any clinical data, related to the scheduling of Syndros under the Controlled Substances Act. The FDA determined that this information constituted a major amendment to this New Drug Application and exercised its option to extend the PDUFA date to provide the FDA time to complete its review.

“Insys is in negotiations concerning the scheduling of Syndros and is working closely with the Agency,” stated Steve Sherman, Sr. Vice President of Regulatory Affairs, Insys Therapeutics. “We hope to resolve this issue shortly and this extension demonstrates the Agency’s willingness to review our new data and work with us going forward.”

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 strives to address the clinical shortcomings of existing commercial products. The Company submitted a New Drug Application to the U.S. Food and Drug Administration for 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 capsules. Insys is developing a pipeline of sublingual sprays, as well as synthetic pharmaceutical cannabidiol.

Forward-Looking Statements
This press release contains forward-looking statements including related to our PDUFA action (goal) date of July 1, 2016. These forward-looking statements are based on management's expectations and assumptions as of the date of this press 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 December 31, 2014 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 press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

Investor Contact:

Lisa M. Wilson

President

In-Site Communications, Inc.

Phone: 212-452-2793

Email: lwilson@insitecony.com

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