Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced positive
regulatory guidance from a recent meeting with the U.S. Food and
Drug Administration (FDA) regarding REMOXY (extended-release
oxycodone capsules CII), its lead drug candidate. The Company
will host a conference call tomorrow morning at 8am EDT to discuss
REMOXY, and to present a corporate update around partnership
discussions and advances to its pipeline.
“In recent weeks we have worked closely with the
FDA,” said Remi Barbier, President & CEO. “We appreciate their
guidance, we understand their new requirements and we believe we’re
now on track to make expeditious progress toward a resubmission of
the REMOXY NDA.”
Pain Therapeutics and the FDA met on February
13, 2017, to discuss REMOXY. During this meeting, agreement
was reached on additional studies that are needed for REMOXY’s
approval. We expect to complete these studies by year-end
2017, at a cost of approximately $3-4 million. Following completion
of these studies, we intend to have a pre-NDA meeting with the FDA,
followed by resubmission of the REMOXY NDA, with anticipated
Priority Review, under 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act.
Final Minutes of our FDA discussions confirm two
requirements are needed for the resubmission of the REMOXY NDA:
- To conduct a clinical abuse potential study via the intranasal
route of abuse; and
- To conduct a non-clinical abuse potential study using household
solvents.
CLINICAL (INTRANASAL) ABUSE POTENTIAL
STUDYREMOXY has a sticky, high-viscosity gel formulation
that cannot be snorted. Therefore, our intranasal study
will ask human volunteers to self-administer into their nostrils
REMOXY, placebo or an active comparator. Positive data in one
intranasal study is adequate to support a label claim against the
intranasal route of abuse. We previously generated positive
results using REMOXY under similar test conditions in a large
animal model.
NON-CLINICAL ABUSE POTENTIAL
STUDYREMOXY’s sticky, high-viscosity formulation cannot be
pulled through a normal size syringe. This feature makes it
difficult to abuse REMOXY via simple injection. Therefore, we
will conduct an abuse potential study in a lab using thin films of
REMOXY smeared on glass plates to assess how household solvents
affect the formulation. We plan to generate these data
against comparator products. Positive data in this study is
adequate to support a label claim against the injection route of
abuse. We previously generated positive results using REMOXY
under similar test conditions.
Our recent discussions with the FDA did not
raise any issues around safety, drug efficacy, manufacturing,
stability or other drug development topics.
Conference CallWe will host a
conference call on Tuesday, March 21st, at 8am Eastern time to
discuss REMOXY, and to present a corporate update around
partnership discussions and advances to its pipeline. To
participate in this conference call in the U.S., please dial
toll-free 1-877-407-4018 or international 1-201-689-8471.
To hear the conference call live via the
internet, please visit www.paintrials.com. About two hours
following the live call, a replay of the conference call will be
available by phone through Friday, March 31, 2017. To listen
to a replay of the call, in the U.S. please dial toll-free
1-844-512-2921, or international 1-412-317-6671, and press replay
number 13658173.
About REMOXY ER (extended-release
oxycodone capsules CII)REMOXY 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. REMOXY’s thick,
sticky, high-viscosity gel formulation may deter unapproved routes
of drug administration, such as injection, snorting or smoking.
REMOXY targets the multi-billion dollar marketplace for
long-acting oxycodone.
We own exclusive, worldwide commercial rights to
REMOXY.
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 discussions with the FDA; the
abuse-deterrent properties and potential benefits of REMOXY;
progress towards a resubmission plan for the REMOXY NDA; and timing
or estimated costs of studies and actions needed to resubmit the
REMOXY NDA to the FDA. 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 conduct the studies and
activities 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
Pain Therapeutics, Inc.
proddy@paintrials.com
(512) 501-2450
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