CUPERTINO, Calif., Sept. 26, 2016 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that its licensee, Pain
Therapeutics (Nasdaq: PTIE) has received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) for Pain
Therapeutics' New Drug Application (NDA) for REMOXY® ER
(oxycodone) extended-release capsules CII. Based on its
review, the FDA has determined that the NDA cannot be approved in
its present form and specifies additional actions and data that are
needed for drug approval.
In a press release issued this morning by Pain Therapeutics,
Pain Therapeutics states that "The CRL focuses on the
abuse-deterrent properties of REMOXY ER and proposed drug
labeling. The CRL makes no mention of clinical safety, drug
efficacy, manufacturing, stability, bioequivalence or any other
issues from a prior Complete Response Letter."
The announcement continues that "Pain Therapeutics is evaluating
the CRL and plan further discussions with the FDA. The CRL
specifies additional actions that are needed in order to obtain
approval of REMOXY ER with label claims against three routes of
abuse (i.e., injection, inhalation and snorting). These
actions may take approximately a year to conduct and may cost
approximately $5MM, pending discussions with the FDA and outside
clinical/regulatory consultants."
In addition, the Pain Therapeutics provides the following
details of the Complete Response Letter (CRL):
"The CRL focuses on the actions and studies that are needed in
order to obtain approval of REMOXY ER with label claims on three
routes of abuse (i.e., injection, inhalation and snorting). In
conducting the following studies, we will generally compare REMOXY
ER vs. one or more commercially available oxycodone ER drug
product:
- To support a potential drug label claim against abuse by
injection: Repeat an injectability/syringeability study using
thin films of drug, smaller volumes of solvents, additional mixed
solvents and alternative extraction methods and syringe
filter.
- To support a potential drug label claim against abuse by
inhalation: Repeat a volatilization study using the same
thickness for each drug to increase surface area.
- To support a potential drug label claim against abuse by
snorting: Conduct an intranasal abuse potential study in human
volunteers (i.e., not the animal data we had submitted) with drug
applied directly inside the human nasal cavity.
In addition, we had proposed in the REMOXY NDA a label claim
against abuse by chewing. Our proposal was based on clinical
results of an oral human abuse potential study that met all four
co-primary endpoints with statistical significance and that also
met several, but not all, secondary endpoints. The CRL asks
us to submit a revised proposed label to indicate results of this
study do not support a label claim against abuse by chewing."
In December 2002, DURECT licensed
to Pain Therapeutics the exclusive right to develop and
commercialize on a worldwide basis REMOXY ER and other
specified opioid analgesics utilizing DURECT's ORADUR
extended-release, abuse-deterrent technology. Under the terms of
that license, Pain Therapeutics funds the development program
including reimbursing DURECT for formulation and other work
performed for Pain Therapeutics. DURECT may also receive
additional payments if certain development and regulatory
milestones are achieved. DURECT is eligible to also receive
royalties of between 6.0% to 11.5% of net sales if REMOXY ER is
commercialized, and may receive additional income from the sale of
key excipients supplied by DURECT for use in the manufacture of
REMOXY ER.
About DURECT Corporation
DURECT is a biopharmaceutical company focused on two areas of
active drug development: new therapeutics based on its proprietary
drug delivery platforms and new chemical entities derived from its
Epigenomic Regulator Program. DURECT's current focus is on
pain management, CNS disorders, acute organ injury, and metabolic
diseases such as NAFLD/NASH. Late
stage development programs utilizing DURECT's drug delivery
technologies include POSIMIR®
(SABER®-Bupivacaine) and REMOXY® ER
(oxycodone) extended-release capsules CII. DURECT's
Epigenomic Regulator Program includes the lead molecule DUR-928 in
Phase 1 development. DUR-928 is an endogenous small molecule
that modulates lipid homeostasis, inflammation and cell
survival. For more information, please visit
www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY ER, its
potential attributes including its potential uses and features,
Pain Therapeutics' on-going review by and interactions with FDA
regarding approval of the REMOXY ER NDA, potential additional
studies that Pain Therapeutics may conduct, the potential of
resolving all outstanding regulatory concerns regarding REMOXY ER
and the amount of time it will take to do so, and potential
payments under DURECT's agreement with Pain Therapeutics 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, Pain Therapeutics may not be able
to adequately address all of FDA's concerns regarding the REMOXY ER
NDA or there could be a delay in addressing such concerns, the
potential that FDA may not grant regulatory approval of REMOXY ER,
further delays and additional costs due to requirements imposed by
the FDA, the risk that Pain Therapeutics may terminate plans to
develop and commercialize REMOXY ER,the risks of obtaining
marketplace acceptance of REMOXY, developments of products or
technologies by current or future competitors, avoiding infringing
patents held by other parties and securing and defending patents
related to REMOXY. Further information regarding these and
other risks is included under the heading "Risk Factors" in
DURECT's Form 10-Q dated August 2,
2016 filed with the Securities and Exchange Commission.
NOTE: POSIMIR®, ORADUR® and
SABER® are trademarks of DURECT Corporation. REMOXY ER,
POSIMIR and DUR-928 are drug candidates under development and have
not been approved for commercialization by the U.S. Food and Drug
Administration or other health authorities.
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SOURCE DURECT Corporation