Insys: U.S. Patents' Listing On SUBSYS Use And Formulation In FDA's Orange Book

(RTTNews) - Insys Therapeutics, Inc. (INSY) announced that the U.S. Food and Drug Administration or FDA has listed U.S. Patent Nos. 8,486,972 and 8,486,973 in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Both of these patents cover SUBSYS brand fentanyl sold by Insys and would expire no sooner than 2027. The '972 patent covers the SUBSYS sublingual fentanyl spray formulation, whereas the '973 patent covers the use of the SUBSYS sublingual fentanyl spray for the treatment of pain.

The proprietary formulation of the '972 patent is utilized for delivering fentanyl directly to the sublingual mucosa to achieve appreciable plasma concentration levels within 5 minutes. This unique formulation differs from other fentanyl formulations in that it is readily absorbed bringing quick and effective pain relief to the patient without the need for injections or IVs. The methods included in the '973 patent cover the treatment of a patient suffering from pain by administration of the formulation described in the '972 patent.

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. SUBSYS is available only through a restricted program called the Transmucosal Immediate-Release Fentanyl REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

SUBSYS is a sublingual spray formulation of free fentanyl in a novel single unit-dose delivery device which disperses a fine mist over a broad sublingual area.