Insys Therapeutics Reports Listing of US Patents Covering SUBSYS Use, Formulation in FDA's Orange Book

Insys Therapeutics, Inc.(NASDAQ: INSY), a pharmaceutical company focused on commercial-stagespecialty pharmaceuticals, announced today that the U.S. Food andDrug Administration (FDA) has listed U.S. Patent Nos. 8,486,972 ('972patent) and 8,486,973 ('973 patent) in its Approved Drug Productswith Therapeutic Equivalence Evaluations, or Orange Book. Both ofthese patents cover SUBSYS brand fentanyl sold by Insys and willexpire no sooner than 2027. The '972 patent covers the SUBSYSsublingual fentanyl spray formulation, while the '973 patent coversthe use of the SUBSYS sublingual fentanyl spray for the treatment ofpain. The proprietary formulation of the '972 patent is useful fordelivering fentanyl directly to the sublingual mucosa to achieveappreciable plasma concentration levels within 5 minutes. This uniqueformulation differs from other fentanyl formulations in that it isreadily absorbed bringing quick and effective pain relief to thepatient without the need for injections or IVs. The methods includedin the '973 patent cover the treatment of a patient suffering frompain by administration of the formulation described in the '972patent.Important SUBSYS Safety Information-- Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.-- Keep out of reach of children.-- Use with CYP3A4 inhibitors may cause fatal respiratory depression.-- When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS.-- When dispensing, do not substitute with any other fentanyl products.-- Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.-- SUBSYS is available only through a restricted program called the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.