CUPERTINO, Calif., Oct. 19, 2017 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today reported that PERSIST, the Phase 3
clinical trial for POSIMIR®
(SABER®-Bupivacaine), did not meet its primary efficacy
endpoint of reduction in pain on movement over the first 48 hours
after surgery as compared to standard bupivacaine
HCl. While results trended in favor of POSIMIR versus
the comparator, they did not achieve statistical
significance. POSIMIR is an investigational drug candidate
being developed for the treatment of post-surgical pain.
"We are very surprised and disappointed by these results, which
we will be trying to understand more fully over the coming weeks,"
said James E. Brown, President and
CEO of DURECT Corporation. "We appreciate the efforts of the
investigators and patients who participated in PERSIST, and we
thank Sandoz for their support."
About POSIMIR (SABER-Bupivacaine)
POSIMIR is an investigational extended-release depot utilizing
DURECT's patented SABER technology intended to continuously deliver
bupivacaine to the surgical site for 72 hours to provide up to
three days of continuous pain relief after surgery. POSIMIR
is a drug candidate under development and has not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities.
About the DURECT / Sandoz Collaboration
In May 2017, DURECT and Sandoz AG
("Sandoz") entered into a license agreement to develop and market
POSIMIR in the United States, and
the agreement became effective in June
2017. DURECT retains commercialization rights in the
rest of the world. Under terms of the agreement, Sandoz made
an upfront payment of $20 million,
with the potential for up to an additional $43 million in milestone payments based on
successful development and regulatory milestones, and up to an
additional $230 million in
sales-based milestones. DURECT is responsible for the
completion of the ongoing PERSIST Phase 3 clinical trial for
POSIMIR as well as FDA interactions through approval. DURECT
also has certain manufacturing obligations under this
agreement. Sandoz will have exclusive commercialization
rights in the United States upon
regulatory approval with sole funding responsibility for
commercialization activities. Sandoz will pay the Company a
tiered double-digit royalty on product sales for a defined period,
after which the license granted to Sandoz shall convert to a
non-exclusive, fully paid, royalty-free, irrevocable and perpetual
license. Given the failure of PERSIST to achieve the primary
endpoint, Sandoz has the right to terminate the agreement upon
thirty (30) days prior written notice to DURECT.
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 1 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, chronic metabolic diseases such as
nonalcoholic fatty liver disease (NAFLD), nonalcoholic
steatohepatitis (NASH) and other liver diseases with both broad and
orphan populations, and inflammatory skin conditions such as
psoriasis. DURECT's advanced oral, injectable, and
transdermal 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. In addition, for the
assignment of certain patent rights, DURECT may receive a milestone
payment from development and single digit sales based earn-out
payments from sale of Indivior's RBP-7000 investigational drug for
schizophrenia, for which Indivior recently submitted an NDA.
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 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 potential
benefits and uses of our drug candidates, including the potential
use of POSIMIR to treat post-surgical pain, the potential milestone
payments and royalties receivable from Sandoz, the potential
milestone payment and single-digit sales based earn-out payments
receivable from Indivior, and the potential use of DUR-928 to treat
NAFLD, NASH, other liver diseases, acute organ injury or
inflammatory skin conditions such as psoriasis 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 Sandoz will terminate our agreement with
them, that the results of the PERSIST trial lead us to terminate
development of POSIMIR or increase the time and expense required to
seek regulatory approval, and the risk that DUR-928 will not be
found to be safe or effective in current or future clinical
trials. Further information regarding these and other risks
is included in DURECT's Form 10-Q filed on August 5, 2017 under the heading "Risk
Factors."
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SOURCE DURECT Corporation