CUPERTINO, Calif., Feb. 27, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced it has completed a
comprehensive review of its POSIMIR® (bupivacaine
extended-release solution) program and plans to submit a full
response to the Complete Response Letter (CRL) it previously
received from U.S. Food and Drug Administration (FDA). The
submission will request FDA approval of POSIMIR based on what the
Company and its advisors believe is adequate evidence of both
safety and efficacy.
DURECT commissioned the advisory services of Dr. Lee S. Simon to evaluate the adequacy of the
existing POSIMIR package to address the issues raised in FDA
correspondence, including the CRL. 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. Dr. Simon is a Principal at SDG, LLC, an FDA advisory
firm. Under Dr. Simon's leadership, the Company conducted a
thorough review of the data and regulatory package for POSIMIR,
including extensive analyses of the data from the PERSIST clinical
study which the Company conducted at the FDA's request. The review
of the data package was in the context of the feedback received
from FDA, including the CRL and other FDA communications, in order
to make a determination as to next steps for POSIMIR. Based on
these analyses, the Company has decided to move forward and Dr.
Simon is leading the process of preparing a submission to formally
respond to the CRL. As the submission is intended to be a full
response to a CRL, as opposed to a new NDA submission, the Company
expects a 6-month FDA review period. The Company expects to
make the submission in the first half of 2019.
"Working closely with DURECT's internal team, SDG has conducted
a thorough review of the POSIMIR program. We believe that the
present data package, which includes multiple adequate and well
controlled trials, addresses the issues raised in the FDA's
Complete Response Letter and, therefore, submission of a full
response to the CRL is warranted," stated Dr. Simon.
"While the main focus of DURECT remains on our Epigenetic
Regulator program and DUR-928, we also have legacy programs, like
POSIMIR, that have significant potential value. We greatly
appreciate Dr. Simon's guidance and expertise in thoroughly
evaluating the POSIMIR program and the leadership he is providing
to our team in preparing the response," said James E. Brown, President and CEO of DURECT. "We
believe that, if approved, POSIMIR has an important role to play in
addressing the need for additional long-acting, non-opioid products
in the post-operative pain setting. If this strategy is successful
we would seek to partner POSIMIR which would provide financial
resources that could be directed toward the development of
DUR-928."
About POSIMIR
POSIMIR is the Company's investigational post-operative pain
relief depot product that utilizes DURECT's patented
SABER® technology and is designed to deliver bupivacaine
to provide up to 3 days of pain relief 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 POSIMIR for the treatment of
post-surgical pain for up to 3 days.
In two completed adequate and well-controlled clinical trials,
conducted in patients undergoing surgeries for inguinal hernia and
subacromial decompression (shoulder), POSIMIR demonstrated a
significant decrease in pain and opioid use over the 0-72 hour
period following surgery as compared to placebo. DURECT
believes that these completed trials support the 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 safety data from the PERSIST trial
included, there are now sufficient data to address FDA's issues
raised in the CRL.
Market Opportunity
According to data published by the Center for Disease Control
and Prevention, there are approximately 72 million ambulatory
and inpatient surgical procedures performed annually in the U.S.
Insufficient postoperative pain control remains a significant
problem, with studies indicating that approximately 65% of patients
experience moderate-to-extreme pain after surgery. The current
standard of care for post-surgical pain includes a variety of
opiate and non-opiate analgesics and muscle relaxants. While
systemic opioids can effectively control post-surgical pain, they
commonly cause side effects including drowsiness, constipation,
nausea and vomiting, and cognitive impairment. Effective pain
management can be compromised if patients fail to adhere to
recommended dosing regimens because they are suffering from these
side effects. Post-surgical pain also can be treated effectively
with local anesthetics; however, their usefulness often is limited
by their short duration of action.
Dial-In &
Webcast Information
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Wednesday,
February 27 @ 10:30 am Eastern Time/7:30 am Pacific
Time
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Domestic:
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1-800-347-6311
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International:
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1-323-794-2094
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Conference
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3700258
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Webcast:
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http://public.viavid.com/index.php?id=133417
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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 chronic liver diseases such as nonalcoholic steatohepatitis
(NASH), acute organ injury such as Alcoholic Hepatitis (AH) and
acute kidney injury (AKI), 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. Late stage 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
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 approved by the FDA in July 2018 and became commercially available in
the U.S. in November 2018. For more information on DURECT,
please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding future events and
expectations, including without limitation DURECT's plans to submit
a full response to the FDA's Complete Response Letter, the time for
the FDA to respond to such submission, the potential regulatory
approval of POSIMIR by the FDA, the potential uses and benefits of
POSIMIR and the possibility of finding a commercial partner for
POSIMIR to provide financial resources that could be directed
towards the development of DUR-928, as well as the potential
benefits of DUR-928 to treat NASH and other hepatic and renal
diseases, acute organ injury or inflammatory skin conditions such
as psoriasis and atopic dermatitis, and the potential for DURECT to
receive sales-based earn-out payments from Indivior from its sales
of PERSERIS to treat schizophrenia 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 will treat the Company's submission as a new
NDA rather than a full response to the CRL, that the FDA will
require additional trials or additional information regarding
POSIMIR, the risk of potential adverse effects arising from the
testing or use of DUR-928, the Company's ability to avoid
infringing patents held by other parties and secure and defend
patents of our own patents, and the Company's ability to manage and
obtain capital to fund its operations and expenses. Further
information regarding these and other risks is included in DURECT's
Form 10-Q on November 8, 2018 under
the heading "Risk Factors."
NOTE: ORADUR®, 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. For PERSERIS full
prescribing information, visit www.perseris.com.
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SOURCE DURECT Corporation