CUPERTINO, Calif., June 22, 2017 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced that patient enrollment has been
completed in PERSIST, the pivotal Phase 3 clinical trial of
POSIMIR® (SABER®-Bupivacaine), an investigational locally acting,
non-opioid analgesic intended to provide up to three days of
continuous pain relief after surgery.
"The early completion of enrollment in PERSIST is an important
milestone for our POSIMIR development program," said James E. Brown, President and CEO of DURECT
Corporation. "We look forward to completing patient follow-up
visits during the third quarter and announcing top-line data in the
fourth quarter of this year."
In May 2017, DURECT signed a
development and commercialization agreement with Sandoz AG, a
division of Novartis, covering the United States. Under the
terms of the agreement, Sandoz made an upfront payment to DURECT of
$20 million following review under
the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976,
with the potential for up to an additional $43 million in development and regulatory
milestones, up to an additional $230
million in sales-based milestones, as well as a tiered
double-digit royalty on product sales in the United States.
DURECT remains responsible for the completion of the ongoing
PERSIST Phase 3 clinical trial for POSIMIR as well as FDA
interactions through approval.
About PERSIST
PERSIST is a Phase 3 clinical trial consisting of patients
undergoing cholecystectomy (gallbladder removal) surgery.
Part 1 of PERSIST consists of 92 patients receiving either POSIMIR
or placebo, and Part 2 consists of 296 patients receiving either
POSIMIR or standard bupivacaine HCl. The primary efficacy
endpoint for Part 2 is pain reduction on movement from 0-48 hours
after surgery, with other key secondary endpoints including pain
reduction on movement from 0-72 hours after surgery and 72-hour
opioid use. In a previous clinical trial of 50 patients
undergoing laparoscopic cholecystectomy, POSIMIR was compared with
the active control bupivacaine HCl, against which POSIMIR
demonstrated in a post hoc analysis an approximately 25% reduction
in pain intensity on movement for the first 3 days after surgery
(p=0.024) and for the first 2 days after surgery (p=0.0198), using
the same statistical methodology specified for the current trial.
There can be no assurance that the PERSIST trial will show similar
results, or provide sufficient data for FDA approval.
About POSIMIR® (SABER-Bupivacaine)
POSIMIR is an investigational extended-release depot utilizing
DURECT's patented SABER technology intended to continuously deliver
bupivacaine to the surgical site for 72 hours, to provide up to
three days of continuous pain relief after surgery. POSIMIR
is a drug candidate under development and has not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities.
About DURECT
DURECT is a biopharmaceutical company actively developing new
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 1 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, chronic metabolic diseases such as
nonalcoholic fatty liver disease (NAFLD), nonalcoholic
steatohepatitis (NASH) and other liver diseases with both broad and
orphan populations, and inflammatory skin conditions such as
psoriasis. DURECT's advanced oral, injectable, and
transdermal delivery technologies are designed to enable new
indications and enhanced attributes for small-molecule and biologic
drugs. One late-stage product candidate in this category is
POSIMIR® (SABER®-Bupivacaine), an
investigational locally-acting, non-opioid analgesic intended to
provide up to 3 days of continuous pain relief after surgery.
Another late stage product candidate is REMOXY® ER
(oxycodone), an investigational pain control drug based on DURECT's
ORADUR® technology. For more information, please
visit www.durect.com.
NOTE: POSIMIR®, SABER®, and
ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners. POSIMIR,
DUR-928, and REMOXY ER are drug candidates under development and
have not been approved for commercialization by the U.S. Food and
Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential
benefits and uses of our drug candidates, including the potential
use of POSIMIR to treat post-surgical pain, the anticipated timing
of the announcing of top-line results from the PERSIST trial, the
potential milestone payments and royalties receivable from Sandoz,
and the potential use of DUR-928 to treat NAFLD, NASH, other liver
diseases, acute organ injury or inflammatory skin conditions such
as psoriasis 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
PERSIST clinical trial of POSIMIR will take longer to analyze than
anticipated or result in data that will not support a successful
NDA resubmission or product approval, failure to achieve the
performance milestones or commercial sales that trigger the
referenced payments or royalties, possible adverse events
associated with the use of POSIMIR, delays and costs due to
additional work or other requirements imposed by regulatory
agencies for continued development, approval or sale of POSIMIR,
our ability to manufacture, commercialize and obtain marketplace
acceptance of POSIMIR, and avoid infringing patents held by other
parties and secure and defend patents of our own, and risks related
to our ability to obtain capital to fund operations and expenses.
Further information regarding these and other risks is included in
DURECT's Form 10-Q filed on May 10,
2017 under the heading "Risk Factors."
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SOURCE DURECT Corporation