Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for REMOXY ER
June 26 2018 - 5:35PM
Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company,
today announced that a joint meeting of the Anesthetic and
Analgesic Drug Products Advisory Committee and Drug Safety and Risk
Management Advisory Committee of the U.S. Food and Drug
Administration (FDA) voted 14 to 3 against the approval of REMOXY
ER (oxycodone extended-release capsules) 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.
REMOXY ER, the Company’s lead product candidate,
is an abuse-deterrent, extended-release, oral formulation of
oxycodone, a widely prescribed opioid medication. The FDA has
set a Prescription Drug User Fee Act (PDUFA) target action date of
August 7, 2018 for completion of its review of the New Drug
Application (NDA) for REMOXY ER.
About REMOXY ER
(extended-release oxycodone capsules CII)REMOXY ER is in
registration with the US Food and Drug Administration (FDA) as a
new type of abuse-deterrent, twice-daily, capsule gel formulation
of oral oxycodone, a strong opioid drug. REMOXY ER has
physical/chemical properties intended to deter abuse and still
provide 12 hours of steady pain relief when properly prescribed by
physician and used appropriately by patients.
Studies were extensive. The clinical
efficacy of REMOXY ER was established in a Phase III study
conducted under a Special Protocol Assessment. In total, over
2,400 subjects were exposed to REMOXY ER in 30 clinical
studies. 9,000 unique data points were generated from 11 lab
studies. The assessment of REMOXY ER’s abuse deterrence is
supported by data from FDA Category 1 (lab), Category 2
(pharmacokinetic) and Category 3 (human abuse potential)
studies. In addition, in November 2017 the Company and FDA
held a pre-NDA meeting to confirm the sufficiency of data included
in the REMOXY ER NDA resubmission.
REMOXY ER has a thick, sticky, high viscosity,
hydrophobic, gel formulation that abusers cannot cut, grate or
divide into smaller discrete particle sizes. The gel
formulation resists syringe-ability, injection, and rapid
extraction in ingestible solvents. REMOXY ER’s high viscosity
and adhesive properties also cause it to stick to tools and
equipment used for abuse. When exposed to heat, REMOXY ER
releases an irritant to the eyes and lungs. REMOXY ER resists
dose-dumping when challenged by alcohol and common physical and
chemical manipulations.
We are requesting marketing approval of REMOXY
ER as an analgesic drug with properties that can be expected to
deter against injection, snorting and inhalation/smoking routes of
abuse.
REMOXY ER intends to address the public health
epidemic related to prescription opioids by advancing the science
of abuse deterrence, providing an additional treatment option for
physicians and patients, and increasing the range of available
abuse deterrent technologies.
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.
Our Pipeline of Drug Assets
Includes:FENROCK™ (transdermal fentanyl
patch system) – This is 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 – This proprietary,
small molecule drug candidate is aimed at 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 – This is a
proprietary blood-based test to detect Alzheimer’s disease.
PTI-125DX is an early-stage program, substantially funded by a
research grant award from the NIH.
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.
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; the
potential approval by the FDA of REMOXY ER; or the therapeutic and
commercial value, if any, of our pipeline of drug
assets. The Company cautions that
forward-looking statements are inherently uncertain. 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; the need to
raise additional funding from time-to-time, and the potential for
abuse-deterrent pain medications or other competing products to be
developed by competitors and potential competitors or others.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. Except as required by law, the Company
disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this press
release. 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 (SEC), which are available on the SEC's website
at www.sec.gov.
For More Information Contact:Ruth
ArayaPain Therapeutics, Inc.IR@paintrials.com(512) 501-2485
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