CUPERTINO, Calif., Sept. 18, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that Orient Pharma Co.,
Ltd., its licensee for certain Asian and South Pacific countries,
has informed DURECT that it has obtained marketing authorization
from the Ministry of Health and Welfare in Taiwan for Methydur Sustained Release
Capsules. Methydur Sustained Release Capsules are indicated
for the treatment of attention deficit hyperactivity disorder
(ADHD) and will be available in three strengths (22 mg, 33 mg and
44 mg) in Taiwan. Orient
Pharma also has stated that it expects to have Methydur Sustained
Release Capsules commercially available in Taiwan in 2019, while seeking a partner in
China and pursuing regulatory
approvals in selected other countries where it has
commercialization rights and a commercialization presence.
"We congratulate Orient Pharma on this new drug approval which
will offer an alternative treatment for those patients suffering
from ADHD in Taiwan," said
James E. Brown, President and CEO of
DURECT Corporation. "We are pleased to see this first
marketing approval for a product utilizing the ORADUR technology
and the second recent approval of a product utilizing our
patents."
According to Orient Pharma, supporting the new drug application
was a Phase 3, multi-center, randomized, double-blind, placebo
controlled, two-way cross-over study designed to demonstrate the
efficacy and safety of Methydur Sustained Release Capsules in
children and adolescents with ADHD aged 6 to 18 years. There
were 110 subjects enrolled in this study, of which 100 evaluable
subjects completed the study. For the primary efficacy
endpoint, Orient Pharma observed a statistically significant
difference between Methydur Sustained Release Capsules and Placebo
treatments in the mean change of total score for the Swanson,
Nolan, and Pelham-IV (SNAP-IV) teacher form (p=0.0044 for the
intent to treat population and p=0.0104 for the per protocol
population). Orient Pharma's safety analysis indicates that
the incidence of adverse events with Methydur Sustained Release
Capsules was similar to other approved Methylphenidate
products.
About the DURECT – Orient Pharma Relationship
In August 2009, DURECT entered
into a development and license agreement with Orient Pharma, a
diversified multinational pharmaceutical, healthcare and consumer
products company with headquarters in Taiwan. In this
agreement, DURECT granted to Orient Pharma the development and
commercialization rights to ORADUR-Methylphenidate ER Capsule
(Methydur Sustained Released Capsules) in certain defined Asian and
South Pacific countries. DURECT retains rights to North America, Europe, Japan
and all other countries not specifically licensed to Orient
Pharma. If commercialized, DURECT will be entitled to receive
a royalty on sales of Methydur Sustained Release Capsules by Orient
Pharma. Orient Pharma has also committed to supply a portion of the
commercial requirements in territories other than the United States for Methydur Sustained
Release Capsules.
About ORADUR® Technology
ORADUR is a proprietary technology designed to transform
short-acting oral capsule dosage forms into sustained release oral
products, with the added potential benefit of resisting common
methods of prescription drug misuse and abuse compared to other
controlled release dosage forms on the market today.
About DURECT
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, hepatic and
renal diseases such as nonalcoholic steatohepatitis (NASH) and
Primary Sclerosing Cholangitis (PSC), 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. 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.
In addition, for the assignment of certain patent rights, DURECT
will receive single digit sales-based earn-out payments from U.S.
net sales of Indivior's PERSERIS™ (risperidone) drug for
schizophrenia, which was approved in July 2018. For more
information, please visit www.durect.com.
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.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential
benefits and uses of drug candidates, including the potential
commercial sale of Orient Pharma's Methydur Sustained Release
Capsules to treat ADHD and Indivior's PERSERIS to treat
schizophrenia, the potential royalty payments receivable from
Orient Pharma and earn-out payments receivable from Indivior, as
well as the potential use of POSIMIR to treat post-surgical pain,
and the potential use of DUR-928 to treat Alcoholic Hepatitis,
hepatic and renal diseases such as nonalcoholic steatohepatitis
(NASH) and Primary Sclerosing Cholangitis (PSC), and inflammatory
skin conditions such as psoriasis and atopic dermatitis 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 Orient Pharma will
not launch Methydur Sustained Release Capsules commercially in its
territories or that it will not obtain market acceptance and
meaningful sales, that Indivior will not launch PERSERIS
commercially or that it will not obtain market acceptance and
meaningful sales, as well as possible adverse events associated
with the use of PERSERIS, Methydur Sustained Release Capsules,
POSIMIR and DUR-928, delays and costs due to additional work or
other requirements imposed by regulatory agencies for continued
development, approval or sale of POSIMIR and DUR-928, and the
possibility that studies of DUR-928 will not replicate results from
earlier preclinical or clinical trials. Further information
regarding risks related to DUR-928 and POSIMIR and other risks
related to DURECT is included in DURECT's Form 10-Q filed on
August 2, 2018 under the heading
"Risk Factors."
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SOURCE DURECT Corporation