CUPERTINO, Calif., Oct. 2, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) announced today that the U.S. Food and
Drug Administration (FDA) has notified the Company that its Class 2
NDA resubmission for POSIMIR® (bupivacaine
extended-release solution) will be discussed at a meeting of the
Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).
The meeting is tentatively scheduled for January 16, 2020. The FDA had previously assigned
a user fee goal date of December 27,
2019; a new user fee goal date has not been assigned.
DURECT commissioned the advisory services of Dr. Lee S. Simon to lead the Company's preparation
efforts to prepare for the advisory committee meeting. Dr. Simon is
a physician and research scientist who served as the FDA's Division
Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug
Products from 2001 to 2003, and is now a Principal at SDG, LLC, an
FDA advisory firm.
"We look forward to a productive discussion with the advisory
committee," stated James E. Brown,
President and CEO of DURECT. "If approved, we believe that POSIMIR
could help address an important need for new long-acting,
non-opioid pain products in the post-operative pain setting."
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. 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 opioids
consumed 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. DURECT
believes this is a sufficiently sized safety database. DURECT
further believes that, with data from the PERSIST trial included,
there may now be sufficient data to address FDA's issues raised in
the CRL.
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 alcoholic Hepatitis (AH) and acute
kidney injury (AKI), chronic hepatic diseases such as nonalcoholic
steatohepatitis (NASH), 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. 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, a
long-acting injectable SABER-based HIV investigational product
being developed with Gilead, and ORADUR™-Methylphenidate ER
Capsules, approved in Taiwan as
Methydur Sustained Release Capsules, where it is indicated for the
treatment of attention deficit hyperactivity disorder (ADHD).
In addition, for the assignment of certain patent rights, DURECT
receives single digit sales-based earn-out payments from U.S. net
sales of Indivior's PERSERIS™ (risperidone) drug for
schizophrenia, which was commercially launched in February
2019. For more information about DURECT, please visit
www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding future events and
expectations, including without limitation, the anticipated
advisory committee meeting for POSIMIR, potential regulatory
approval of POSIMIR by the FDA, the potential uses and benefits of
POSIMIR, as well as statements about potential uses and benefits of
DUR-928 and DURECT's oral and injectable delivery technologies, and
potential revenues from commercial sales of Indivior's
PERSERIS, 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
FDA advisory committee meeting will be delayed, that the committee
will vote against approval of POSIMIR or make other unfavorable
votes and/or statements about POSIMIR, that the FDA will require
additional trials or additional information regarding POSIMIR, and
the risk that the FDA may not approve the POSIMIR NDA.
Additional risks include the risk that potential adverse effects
may arise from the testing or use of DUR-928, that Gilead will
discontinue the development of the SABER-based long-acting HIV
investigational drug product, that ORADUR-Methylphenidate ER may
not be commercially successful in territories where it is approved
or approved in other territories, that Indivior will not generate
significant sales of PERSERIS, that DURECT may not avoid infringing
patents held by other parties or be unable to secure and defend its
own patents, and DURECT'S ability to manage and obtain capital to
fund operations and expenses. Further information regarding these
and other risks is included in DURECT's Form 10-Q filed on
August 2, 2019 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,
POSIMIR and ORADUR-Methylphenidate ER Capsules are drug candidates
under development and have not been approved for commercialization
by the U.S. Food and Drug Administration or other health
authorities. Full prescribing information for PERSERIS, including
BOXED WARNING, and Medication Guide can be found at
www.perseris.com.
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SOURCE DURECT Corporation