Pain Therapeutics Reports Positive Regulatory Meeting for REMOXY™
December 18 2017 - 8:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company,
today announced that it has successfully concluded a regulatory
meeting with the U.S. Food and Drug Administration (FDA) regarding
REMOXY, a drug candidate for severe chronic pain. The purpose of
this pre-New Drug Application (NDA) meeting was to agree on
submission requirements for the REMOXY NDA under 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act. Following a successful
conclusion of its meeting with the FDA, Pain Therapeutics intends
to resubmit the REMOXY NDA in Q1 2018 with Priority (six-month)
Review.
Pain Therapeutics received comments and
clarification from the FDA on the acceptability of the data to be
included in the REMOXY NDA resubmission, including a recent
intranasal study. All questions were clearly and adequately
addressed, and summarized in official minutes of the meeting
recently issued by the FDA. There are no discrepancies or
requests for clarifications following receipt of final meeting
minutes.
“We appreciate the FDA’s guidance and clarity as
we prepare to resubmit the REMOXY NDA,” said Remi Barbier,
President & CEO of Pain Therapeutics.
About REMOXY ER (extended-release
oxycodone capsules CII)REMOXY ER is a proprietary,
abuse-deterrent, extended-release oral formulation of oxycodone.
The proposed indication for this drug candidate is for "the
management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate." We developed REMOXY
to make oxycodone difficult to abuse yet provide 12 hours of steady
pain relief when used appropriately by patients. In
particular, REMOXY’s thick, sticky, high-viscosity gel-cap
formulation may deter unapproved routes of drug administration,
such as injection, snorting or smoking.
About Opioid AbuseOpioid drugs
such as oxycodone are an important treatment option for patients
with severe chronic pain. However, oxycodone abuse and
diversion remains a serious, persistent problem. Drug overdose
deaths exceeded 64,000 in 2016, according to the Center for Disease
Control (CDC). For over a decade, Pain Therapeutics has
pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight
against prescription drug abuse. ADFs attempt to raise the
bar on prescription drug abuse by making it more difficult, longer
or aversive to tamper with long-acting opioid formulations,
recognizing that no drug can be made abuse-proof.
About Pain Therapeutics, Inc.We
develop proprietary drugs that offer significant improvements to
patients and physicians. Our expertise consists of developing new
drugs and guiding these through various regulatory and development
pathways in preparation for their eventual commercialization.
We generally focus our drug development efforts around disorders of
the nervous system. The FDA has not yet established the
safety or efficacy of our drug candidates.
Our pipeline of drug assets includes:
REMOXY ER
(extended-release oxycodone capsules CII) –
Proprietary abuse-deterrent, twice-daily oral oxycodone for severe
chronic pain. NDA resubmission planned for Q1 2018.
FENROCK™ (transdermal
fentanyl patch system) – Proprietary abuse-deterrent skin
patch for severe pain. Early-stage program, substantially
funded by a research grant award from National Institute on Drug
Abuse (NIDA).
PTI-125 Rx – Proprietary small
molecule drug for the treatment of Alzheimer’s disease. Phase I
clinical-stage program, substantially funded by a research grant
award from the National Institutes of Health (NIH).
PTI-125 Dx – Blood-based
diagnostic/biomarker to detect Alzheimer’s disease. Early-stage
program, substantially funded by a research grant award from the
NIH.
NOTE: REMOXY™ ER and FENROCK™ are trademarks of
Pain Therapeutics, Inc.
Note Regarding Forward-Looking
Statements: This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Pain Therapeutics disclaims any
intent or obligation to update these forward-looking statements,
and claims the protection of the Safe Harbor for forward-looking
statements contained in the Act. Examples of such statements
include, but are not limited to, statements regarding the planned
resubmission of the REMOXY NDA in a timely matter. Such statements
are based on management's current expectations, but actual results
may differ materially due to various factors. Such statements
involve risks and uncertainties, including, but not limited to,
those risks and uncertainties relating to the ability to resubmit
the REMOXY NDA in Q1 2018. For further information regarding
these and other risks related to our business, investors should
consult our filings with the U.S. Securities and Exchange
Commission.
For More Information Contact:Ruth
ArayaPain Therapeutics, Inc.IR@paintrials.com(512) 501-2485
Pain Therapeutics (NASDAQ:PTIE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pain Therapeutics (NASDAQ:PTIE)
Historical Stock Chart
From Apr 2023 to Apr 2024