Pain Therapeutics Announces Upcoming Meeting with FDA
October 30 2017 - 8:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that the U.S.
Food and Drug Administration (FDA) has agreed to a pre-NDA guidance
meeting to discuss the Company’s New Drug Application (NDA)
resubmission for REMOXY ER (oxycodone CII) as a treatment for
severe chronic pain.
The meeting is planned for November 14, 2017 at
FDA headquarters. Pain Therapeutics will provide details of this
FDA meeting after receipt of final meeting minutes. The REMOXY NDA
remains on-track for a planned resubmission in Q1 2018.
The purpose of a pre-NDA meeting is to acquaint
FDA reviewers with the data to be submitted in the NDA, to uncover
any major unresolved problems, including agreement that the NDA
resubmission constitutes a complete response to 2016 Complete
Response Letter, and to discuss the best approach to the
presentation and formatting of data in the NDA.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, recognizing that no drug
can be made abuse-proof.
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:Ruth
ArayaPain Therapeutics, Inc.raraya@paintrials.com(512) 501-2485
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