Insys Therapeutics, Inc.
INSY, a pharmaceutical company focused on commercial-stage
specialty pharmaceuticals, announced today that the U.S. Food and
Drug Administration (FDA) has listed U.S. Patent Nos. 8,486,972 ('972
patent) and 8,486,973 ('973 patent) in its Approved Drug Products
with Therapeutic Equivalence Evaluations, or Orange Book. Both of
these patents cover SUBSYS brand fentanyl sold by Insys and will
expire no sooner than 2027. The '972 patent covers the SUBSYS
sublingual fentanyl spray formulation, while 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 useful 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.
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.
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