CUPERTINO, Calif., July 17, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that the U.S. Food and
Drug Administration (FDA) has acknowledged that the submission of
DURECT's full response to the Complete Response Letter (CRL) it
previously received from FDA related to POSIMIR®
(bupivacaine extended-release solution) is considered by the FDA to
be a complete class 2 response to the CRL. The user fee goal date
is December 27, 2019. The
submission is intended to address the issues raised in the CRL and
seeks 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 first evaluate the adequacy of
the existing POSIMIR package to address the issues raised in FDA
correspondence, including the CRL, and then to lead the Company's
efforts to submit its response to 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, and is now a Principal at SDG, LLC, an FDA advisory
firm.
"We are pleased that the FDA considers our POSIMIR submission to
be complete and has set a user fee goal date of six months after
submission," said James E. Brown,
President and CEO of DURECT. "New non-opioid pain products are much
needed in the post-operative pain setting and we believe that
POSIMIR could be an important contributor."
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 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. Post-surgical pain
also can be treated effectively with local anesthetics; however,
their usefulness often is limited by their short duration of
action.
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. 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 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 time for the FDA to
respond to DURECT's response to the FDA's Complete Response Letter,
the potential regulatory approval of POSIMIR by the FDA, the
potential uses and benefits of and market opportunity for POSIMIR,
as well as the potential use of DUR-928 to treat chronic hepatic
diseases such as NASH, acute organ injuries such as AH and AKI, and
inflammatory skin disorders such as psoriasis and atopic
dermatitis, and the potential for DURECT to receive sales-based
earn-out payments based on sales of Indivior's 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 not act by the user fee goal date, that the FDA
will require additional trials or additional information regarding
POSIMIR, the risk that the FDA may not approve the POSIMIR NDA, the
risk of delays in the enrollment of the ongoing clinical trials of
DUR-928 in NASH, AH and psoriasis, potential adverse effects
arising from the testing or use of DUR-928, the risk that PERSERIS
and Methydur Sustained Release Capsules will not generate material
sales, our ability to avoid infringing patents held by other
parties and secure and defend our own patents, and our ability to
manage and obtain capital to fund our operations and expenses.
Further information regarding these and other risks is included in
DURECT's Form 10-Q for the three months ended March 31, 2019 filed with the Securities and
Exchange Commission on May 7, 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 and 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