CUPERTINO, Calif., March 20, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that its licensee, Pain
Therapeutics (Nasdaq: PTIE), reported yesterday that the U.S. Food
and Drug Administration (FDA) will hold an Advisory Committee
Meeting to discuss the New Drug Application (NDA) for REMOXY ER
(extended release oxycodone CII). REMOXY® ER is
designed as an abuse-deterrent, extended release, capsule
formulation of oxycodone, a prescription drug for severe
pain. The tentative date for the Advisory Committee Meeting
is June 26, 2018. The
Prescription Drug User Fee Act (PDUFA) target date for the REMOXY
ER NDA is August 7, 2018.
About REMOXY ER
REMOXY ER, an investigational drug, is a unique long-acting oral
formulation of oxycodone intended to manage pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate. Based on
DURECT's ORADUR® technology, which is covered by issued
patents and pending patent applications owned by us, REMOXY ER is
designed to discourage common methods of tampering associated with
prescription opioid analgesic misuse and abuse.
In December 2002, DURECT licensed
to Pain Therapeutics worldwide rights to develop and commercialize
REMOXY ER and other oral sustained release drug candidates that use
the ORADUR technology and incorporate certain specified opioid
compounds. DURECT, which is reimbursed for formulation and other
work performed under its agreement with Pain Therapeutics, will
receive additional payments if certain development and regulatory
milestones are achieved with respect to REMOXY ER, and will receive
royalties of between 6.0% to 11.5% of net sales if REMOXY ER is
commercialized, as well as a mark-up on DURECT's supply of key
excipients used in the manufacture of REMOXY ER.
About ORADUR Technology
ORADUR is a proprietary technology designed to transform
short-acting oral capsule dosage forms into sustained release oral
products, with the added benefit of resisting common methods of
prescription drug misuse and abuse compared to other controlled
release dosage forms on the market today.
About DURECT
DURECT is a biopharmaceutical company actively developing new
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 such as alcoholic hepatitis, hepatic and
renal diseases such as nonalcoholic steatohepatitis (NASH) and 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 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.
NOTE: POSIMIR®, SABER®, and
ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners.
POSIMIR, DUR-928, RBP-7000 and REMOXY ER are drug candidates under
development and have not been approved for commercialization by the
U.S. Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding the NDA
resubmission of REMOXY ER, the tentative date for the Advisory
Committee meeting and the target PDUFA date for REMOXY ER, the
potential benefits and uses of DURECT's drug candidates, including
the potential use of DUR-928 to treat PSC, NASH and other
hepatic and renal diseases, alcoholic hepatitis, acute organ injury
or inflammatory skin conditions such as psoriasis and atopic
dermatitis, POSIMIR to treat post-surgical pain, REMOXY ER to treat
pain, Indivior's RBP-7000 to treat schizophrenia, the potential
milestone payments and royalties receivable from Pain Therapeutics,
and the potential milestone payment and earn-out payments
receivable from Indivior, 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 the Advisory Committee will cancel the meeting or recommend
against approval of the REMOXY ER NDA, that the NDA resubmission of
REMOXY ER will not result in product approval by the FDA or will be
met with delays, as well as possible adverse events associated with
the use of POSIMIR, REMOXY ER and DUR-928, delays and costs due to
additional work or other requirements imposed by regulatory
agencies for continued development, approval or sale of POSIMIR,
REMOXY ER and DUR-928, and the possibility that studies of DUR-928
will not replicate results from earlier clinical trials.
Further information regarding risks related to DUR-928, POSIMIR and
REMOXY ER and other risks related to DURECT is included in DURECT's
Form 10-K filed on March 8, 2018
under the heading "Risk Factors."
View original
content:http://www.prnewswire.com/news-releases/durect-announces-fda-advisory-committee-meeting-for-remoxy-er-300616364.html
SOURCE DURECT Corporation