CUPERTINO, Calif., Jan. 16, 2020 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that NASDAQ has
halted trading of the Company's common stock today.
The U.S. Food and Drug Administration's (FDA) Anesthetic and
Analgesic Drug Products Advisory Committee (AADPAC) is holding a
meeting today from 8 a.m. to 5 p.m.
ET to discuss POSIMIR, an investigational medicine for the
treatment of post-surgical pain. Although the FDA considers
the recommendations of the AADPAC, recommendations by the panel are
non-binding, and the final decision regarding pending regulatory
actions for a product is made by the FDA.
The briefing materials and webcast information may be found on
the FDA's website at
https://www.fda.gov/advisory-committees/january-16-2020-meeting-anesthetic-and-analgesic-drug-products-advisory-committee-meeting#event-materials.
About POSIMIR
POSIMIR is the Company's investigational post-operative pain
relief depot product that utilizes DURECT's patented
SABER® technology. POSIMIR is designed to be
administered directly into the surgical site to deliver bupivacaine
for up to three days after surgery. The FDA had previously assigned
a user fee goal date of December 27,
2019; a new user fee goal date has not been assigned.
POSIMIR has not been approved by the FDA for marketing in the U.S.
for any indication.
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 such as AH and acute kidney injury (AKI)
and chronic hepatic diseases such as NASH. DURECT's advanced
oral and injectable delivery technologies are designed to enable
new indications and enhanced attributes for small-molecule and
biologic drugs. Key product candidates in this category
include POSIMIR® (bupivacaine extended-release
solution), an investigational locally-acting, non-opioid analgesic
intended to provide up to 3 days of continuous pain relief after
surgery, and a long-acting injectable SABER-based HIV
investigational product being developed with Gilead. For more
information about DURECT, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential use
of POSIMIR to treat post-operative pain, the potential benefits and
uses of DUR-928 to treat acute organ injury such as AH and acute
kidney injury (AKI) and chronic hepatic diseases such as NASH, and
the potential development of a long-acting injectable SABER-based
HIV product with Gilead 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 risk that the FDA Advisory Committee will not recommend
approval of POSIMIR or that the FDA will not approve POSIMIR or if
it does approve POSIMIR's use, that it will materially restrict its
label, the risk of delays in clinical trials or adverse safety
events from patients administered with DUR-928, the risk that the
ongoing clinical trial of DUR-928 in NASH does not successfully
achieve its endpoints, the risk that placebo controlled studies of
DUR-928 required for regulatory approval will not replicate results
from open label clinical trials or trials with small numbers of
patients or historical controls, the risks that the long-acting
injectable SABER-based HIV investigational product being developed
with Gilead will not succeed or that Gilead will abandon this
program, and the risk of delays and costs due to additional work or
other requirements imposed by regulatory agencies for continued
development, approval or sale of any of our product
candidates. Further information regarding these and other
risks related to DURECT is included in DURECT's Form 10-Q filed on
November 5, 2019 under the heading
"Risk Factors" and in subsequent reports that we file with the
Securities and Exchange Commission.
NOTE: POSIMIR® and SABER® are
trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners. DUR-928 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