Complete Response Letter for REMOXY®
September 26 2016 - 7:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has
received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) on the resubmission of its new drug
application (NDA) for REMOXY ER (oxycodone capsules CII). The
CRL informs that REMOXY ER cannot be approved in its present form
and specifies additional actions and data that are needed for drug
approval.
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.
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.
Conference CallPain
Therapeutics will host a conference call on Monday,
September 26th at 9:00am Eastern time to discuss the
Complete Response Letter. To participate in this conference
call please dial toll-free 1-877-407-4018 (U.S.) or 1-201-689-8471
(international).
Those interested in listening to the conference
call live via the internet may do so by visiting
www.paintrials.com. About two hours following the live call,
a replay of the conference call will be available by phone through
October 3, 2016. To listen to a replay of the call, please
dial toll-free 1-877-870-5176 (U.S.) or 1-858-384-5517
(international) and press pin number 1212590.
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.
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® 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; the abuse-deterrent properties and
potential benefits of REMOXY ER; the estimated time period that may
be required to take the actions requested by the FDA and the
estimated cost of taking such actions. 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 CRL 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, the FDA’s continuing review of REMOXY ER,
the possibility that the FDA may raise additional issues in the
future that were not raised in the past, unexpected adverse side
effects and inadequate therapeutic efficacy. 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.
(512) 501-2450
proddy@paintrials.com
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