Pain Therapeutics to Discuss REMOXY® ER with FDA
December 20 2016 - 9:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced it plans to
meet with the U.S. Food and Drug Administration (FDA) in person on
Monday, February 13, 2017 to discuss the regulatory path forward
for REMOXY ER. The Company will provide details of this FDA
meeting after receipt of final meeting minutes.
Pain Therapeutics is committed to working with
the FDA to gain regulatory approval of REMOXY ER. During its
upcoming meeting with the FDA, the Company plans to open a
scientific dialogue around the intranasal (snorting) route of
abuse. REMOXY ER is a gel formulation that is not suitable
for deep inhalation. The Company believes REMOXY ER’s thick,
sticky, high-viscosity drug mass is a key feature of its abuse
deterrent properties, recognizing that no drug can be made
abuse-proof.
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
ER to make oxycodone difficult to abuse yet provide 12 hours of
steady pain relief when used appropriately by patients. In
particular, REMOXY ER’s thick, sticky, high-viscosity gel
formulation may deter unapproved routes of drug administration,
such as injection, snorting or smoking. REMOXY ER targets the
multi-billion marketplace for long-acting oxycodone.
We own exclusive, worldwide commercial rights to
REMOXY ER.
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. Nearly 19,000
people died from opioid overdose in 2014, according to the National
Institute on Drug Abuse. 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 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, such as chronic pain. The
FDA has not yet established the safety or efficacy of our drug
candidates.
NOTE: REMOXY® ER is a trademark of Pain
Therapeutics, Inc.
Important 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 potential discussions with the
FDA and the abuse-deterrent properties and potential benefits of
REMOXY ER. Such statements are based on management's current
expectations but actual results may vary materially due to various
factors, many of which are beyond the control of management. Drug
development involves substantial risks and uncertainties, including
but not limited to those risks and uncertainties relating to
successfully completing the activities required to address the
issues raised by the FDA in the September 2016 Complete Response
Letter for REMOXY ER and the time required to do so, including the
time required to reach resolution with the FDA on the scope of the
appropriate actions to be undertaken and the possibility that the
FDA may raise additional issues in the future that were not raised
in the past. In addition, the development of abuse-deterrent drug
products is a young and still emerging area of drug development,
with regulatory guidance that may be inconsistent, unclear or still
in development. Such statements are based on management's current
expectations, but actual results may differ materially due to
various factors. 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:
Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.
proddy@paintrials.com
(512) 501-2450
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