CUPERTINO, Calif., June 26, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today reported that a joint meeting of
the Anesthetic and Analgesic Drug Products Advisory Committee and
Drug Safety and Risk Management Advisory Committee of the U.S. Food
and Drug Administration (FDA) voted 14 to 3 against the approval of
REMOXY® ER (oxycodone extended-release capsules) for the
management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate. The development
and commercialization rights of REMOXY ER are held by Pain
Therapeutics (Nasdaq: PTIE) under a license from DURECT. The
Prescription Drug User Fee Act (PDUFA) date for completion of the
review is August 7, 2018.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 2 development, is the lead candidate in DURECT's
Epigenetic Regulator Program. An endogenous, orally
bioavailable small molecule, DUR-928 has been shown in preclinical
studies to play an important regulatory role in lipid homeostasis,
inflammation, and cell survival. Human applications may
include acute organ injury, hepatic and renal diseases such as
nonalcoholic steatohepatitis (NASH) and Primary Sclerosing
Cholangitis (PSC), and inflammatory skin conditions such as
psoriasis and atopic dermatitis. DURECT's advanced oral and
injectable delivery technologies are designed to enable new
indications and enhanced attributes for small-molecule and biologic
drugs. One late stage product candidate in this category is
POSIMIR® (SABER®-Bupivacaine), an
investigational locally-acting, non-opioid analgesic intended to
provide up to 3 days of continuous pain relief after surgery.
Another late stage product candidate is REMOXY® ER
(oxycodone), an investigational pain control drug based on DURECT's
ORADUR® technology, for which the FDA has set a PDUFA
(Prescription Drug User Fee Act) target action date of August 7, 2018. In addition, for the
assignment of certain patent rights, DURECT may receive a milestone
payment upon NDA approval and single digit sales-based earn-out
payments from U.S. net sales of Indivior's RBP-7000 investigational
drug for schizophrenia, for which Indivior has submitted an NDA and
for which the FDA has set a PDUFA target action date of
July 28, 2018. For more
information, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential
benefits and uses of our drug candidates, including the potential
use of REMOXY ER to treat pain, the potential payments
receivable from Pain Therapeutics associated with approval and
commercialization of REMOXY ER, the potential use of DUR-928 to
treat NASH, PSC, acute organ injury or inflammatory skin diseases
such as psoriasis, the potential use of POSIMIR to treat pain and
the potential use of RBP-7000 to treat schizophrenia are
forward-looking statements involving risks and uncertainties that
can cause actual results to differ materially from those in such
forward-looking statements. Potential risks and uncertainties
include, but are not limited to, the risks that REMOXY ER will not
receive product approval by the FDA and fail to achieve the
performance milestones or commercial sales that trigger milestone
payments or royalties, possible adverse events associated with the
use of REMOXY ER, delays and costs due to additional work or other
requirements imposed by regulatory agencies for continued
development, approval or sale of REMOXY ER, the risk that Pain
Therapeutics will discontinue development of REMOXY ER, Pain
Therapeutics' ability to obtain marketplace acceptance of REMOXY
ER, the risk that the clinical trials of our other product
candidates will not be successful, our ability to avoid infringing
patents held by other parties and secure and defend patents of our
own, and risks related to our ability to obtain capital to fund
operations and expenses. Further information regarding these and
other risks is included in DURECT's Form 10-K filed on March 8, 2018 under the heading "Risk
Factors."
NOTE: POSIMIR®, SABER®, and
ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners.
DUR-928, RBP-7000, REMOXY ER and POSIMIR are drug candidates under
development and have not been approved for commercialization by the
U.S. Food and Drug Administration or other health authorities.
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SOURCE DURECT Corporation