Pain Therapeutics Announces FDA Advisory Committee Meeting for REMOXY ER®
March 19 2018 - 7:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company,
announced today that the U.S. Food and Drug Administration (FDA)
will hold an Advisory Committee Meeting to discuss the New Drug
Application (NDA) for REMOXY ER (extended-release oxycodone
CII). The tentative date for this meeting is June 26,
2018. Members of the Advisory Committee review and evaluate
data around safety and effectiveness and make appropriate
recommendations. All final decisions, however, are made by
the FDA. Details of the meeting agenda will be available in
the Federal Register at a later date.
The Prescription Drug User Fee Act (PDUFA)
target date for the REMOXY NDA is August 7, 2018. If
approved, REMOXY ER will be classified as a Schedule II drug,
subject to strict prescribing and dispensing rules. Pain
Therapeutics has included in the NDA submission a comprehensive
Risk Evaluation and Mitigation Strategy (REMS) that is consistent
with current FDA and industry-wide guidelines for extended-release
opioid products. The REMS is intended to control inappropriate
prescribing, misuse and abuse of extended-release opioids while
maintaining patient access to essential pain medications.
About REMOXY ERREMOXY ER is an
abuse-deterrent, extended-release, capsule formulation of oxycodone
(CII), a prescription drug for severe pain. REMOXY ER has a
thick, sticky, high-viscosity capsule formulation designed to deter
unapproved routes of drug administration, such as injection,
snorting or smoking. Pain Therapeutics developed REMOXY ER to
make oxycodone difficult to abuse yet provide 12 hours of steady
pain relief when used appropriately by patients with
pain.
Pain Therapeutics filed the REMOXY NDA through
the 505(b)(2) regulatory pathway.
About Opioid AbuseOpioid drugs
such as oxycodone are an important treatment option for patients
with severe chronic pain. However, oxycodone abuse and
diversion remain serious, persistent problems. Opioid 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.
We own commercial rights worldwide to
all of our drug assets.
Pain Therapeutics’ Pipeline of Drug
Assets Includes:REMOXY® ER
(extended-release oxycodone (CII) capsules) – A proprietary,
abuse-deterrent, twice-daily, prescription drug for severe chronic
pain, currently under regulatory review with a PDUFA target date of
August 7, 2018.
FENROCK™ (transdermal fentanyl
patch system) – A proprietary abuse-deterrent skin patch for severe
pain. FENROCK is an early-stage program, substantially funded
by a research grant award from National Institute on Drug Abuse
(NIDA).
PTI-125 – A proprietary small
molecule drug candidate for the treatment of Alzheimer’s disease.
PTI-125 is a Phase I clinical-stage program, substantially
funded by a research grant award from the National Institutes of
Health (NIH).
PTI-125DX – A blood-based
diagnostic/biomarker to detect Alzheimer’s disease. PTI-125DX
is an 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 abuse deterrent properties of REMOXY ER; the timing
of the regulatory review by the FDA of the REMOXY NDA; and the
potential approval by the FDA of REMOXY ER. 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 development and testing
of our drug candidates; unexpected adverse side effects or
inadequate therapeutic efficacy of our drug candidates; the
uncertainty of patent protection for our intellectual property or
trade secrets; unanticipated additional research and development,
litigation and other costs; and the potential for abuse-deterrent
pain medications or other competing products to be developed by
competitors and potential competitors or others. 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
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