CUPERTINO, Calif., Jan. 17, 2020 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced that the U.S. Food and Drug
Administration's (FDA) Anesthetic and Analgesic Drug Products
Advisory Committee (AADPAC) met yesterday to discuss the Class 2
New Drug Application (NDA) resubmission for POSIMIR®
(bupivacaine extended-release solution). In a split vote on the key
question, six advisory committee members voted to recommend that
the efficacy, safety, and overall risk-benefit profile of POSIMIR
support approval, while six did not support approval based on the
information presented.
Although the FDA considers the recommendations of the AADPAC,
the recommendations by the panel are non-binding. The final
decision regarding pending regulatory actions for a product is made
by the FDA.
"We appreciated this opportunity to present an in depth overview
of our POSIMIR data and discuss it with the committee," stated
James E. Brown, President and CEO of
DURECT. "We are encouraged by the support from a number of the
Committee members. We continue to believe the data meets all of the
regulatory requirements and that the weight of the evidence
supports approval. We look forward to working with the agency as it
completes its review of the POSIMIR application."
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 the POSIMIR Clinical Development Program
The POSIMIR clinical development program was designed to
evaluate the safety and efficacy of a single dose of POSIMIR to
treat post-surgical pain for up to three days.
In two completed adequate and well-controlled clinical trials,
conducted in patients undergoing inguinal hernia repair and
subacromial decompression (shoulder) surgeries, respectively,
POSIMIR demonstrated a significant decrease in pain and opioid
consumption over the 0-72 hour period following surgery as compared
to placebo. DURECT believes that these completed trials support the
safety and efficacy of POSIMIR in post-operative pain and meet the
requirements to be considered pivotal clinical trials.
In all, the Company has completed 16 clinical trials in the
POSIMIR program, involving over 1,400 patients, over 850 of whom
received POSIMIR, with the remainder in control groups.
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 FDA
approval of POSIMIR and 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 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 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 or deemphasize 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