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INSYS Therapeutics Announces FDA Approval of SUBSYS(R) Fentanyl Sublingual Spray

1/5/2012 6:59:31 AM

PHOENIX, AZ--(Marketwire - January 05, 2012) - INSYS Therapeutics (PINKSHEETS: NEOL) announces the US Food and Drug Administration approval of its branded breakthrough cancer pain medication, SUBSYS® fentanyl sublingual spray. SUBSYS is a sublingually-administered formulation of fentanyl in a novel delivery device which offers numerous benefits to patients that experience episodes of breakthrough cancer pain. Breakthrough cancer pain is characterized by sudden, often unpredictable, episodes of intense pain which can peak in severity at three to five minutes despite background pain medication. SUBSYS is approved in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

"INSYS is proud and excited to have SUBSYS approved," said Dr. Larry Dillaha, MD, Chief Medical Officer of INSYS Therapeutics. "INSYS was founded as a specialty pharmaceutical company with a mission to develop products that meet unmet clinical needs, and to contribute to the improvement of supportive care for cancer patients. Being a single-dose sublingual spray, we believe SUBSYS' unique and convenient delivery system will offer an important treatment option for appropriate patients."

Dr. Jeffrey A. Gudin of Englewood Hospital and Medical Center, Englewood, NJ, says about SUBSYS: "With the early onset of action, greater bioavailability, and broadest range of approved strengths, SUBSYS is poised to match the onset and intensity of a breakthrough cancer pain episode."

President and CEO Michael Babich added, "I personally would like to thank all the folks who have helped SUBSYS grow from a concept to a commercially approved product. I am so proud of my coworkers, those who participated in the clinical development and the caregivers who realize the need for products providing benefits to their patients whom suffer from breakthrough cancer pain. We intend to continue to grow our commercial organization and launch this product under the recently approved TIRF REMS Access Program when it is launched later this quarter."

Breakthrough Cancer Pain occurs in patients with cancer and is often defined as a temporary flare in pain that can be quite severe. These flares occur in the context of background pain that is otherwise usually well-controlled on opioids. Breakthrough Cancer Pain episodes can last anywhere from several seconds to hours with the average episode lasting 30 or so minutes. Breakthrough Cancer Pain is believed to occur in approximately 1/3 of patients being treated for cancer and up to 80% of patients with later stage disease.

About INSYS Therapeutics, Inc.
INSYS Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative products that address chemotherapy-induced nausea and vomiting (CINV), pain management and other central nervous system disorders. We develop new formulations and delivery methods for existing drugs in order to achieve enhanced efficacy, faster onset of action, reduced side effects, convenient delivery and increased patient compliance. Our drug development programs are based on existing compounds with known or proven safety, efficacy and commercialization histories. We are focused on leveraging our expertise in the expanding synthetic cannabinoid derivatives and specialized opioid markets to build a portfolio of proprietary products that address the limitations of existing therapies.

Media Contact:
Michael Babich
(602) 910-2617

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