- Study Meets Primary Endpoint
(p<0.01) -
Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced positive
results from a human abuse potential study of its late-stage drug
candidate, REMOXY. Study results indicate that in
non-dependent, recreational opioid users, nasal administration of
REMOXY resulted in significantly lower abuse potential compared to
immediate-release (IR) oxycodone. All study subjects reported
reduced ‘Drug Liking’ ‘Take Drug Again’ and ‘Drug High’ for REMOXY
compared to oxycodone IR. In addition, nasal administration
of REMOXY showed lower exposure to oxycodone, lower peak
concentrations (Cmax) and longer time to peak drug concentration
(Tmax) against comparator drugs, suggesting comparatively lower
abuse potential.
“We believe these data indicate REMOXY may have
limited nasal abuse potential relative to comparator drugs,” said
Remi Barbier, President & CEO. “We have now successfully
completed all studies necessary to resubmit the REMOXY NDA to the
FDA, and plan to do so shortly.”
Design & Methods:This
Category 3 nasal abuse potential study was conducted in accordance
with the U.S. Food and Drug Administration’s (FDA) Guidance for
Industry for Abuse-Deterrent Opioids. In a randomized,
double-blind, active- and placebo-controlled, single-dose, 4-way
crossover study, 38 recreational opioid users with a history of
intranasal drug abuse were enrolled in the study. The primary
endpoint was ‘Drug Liking’. Secondary endpoints included
‘Take Drug Again’, ‘Drug High’ and pupil size. There were
four treatment arms: REMOXY 40 mg intact; REMOXY 40 mg microwaved;
oxycodone IR 40 mg; and placebo. All treatments were
administered nasally. Thirty-six subjects completed the
study. In addition, the first 20 subjects who completed the
double-blind portion of the study also participated in a
supplemental FDA Category 2 treatment arm to measure
pharmacokinetic parameters following the nasal administration of 40
mg crushed OxyContin®.
Top-Line Study Results:REMOXY
intact and microwaved each demonstrated lower VAS scores on the
primary endpoint, Drug Liking (p<0.01) versus oxycodone IR,
indicating that oxycodone IR was significantly preferred over
REMOXY.
On secondary endpoints, REMOXY intact and
microwaved each demonstrated lower scores versus oxycodone IR on
Take Drug Again, Drug High and pupil size (each p<0.001 or
better).
On all pharmacokinetic parameters, REMOXY
resulted in significantly lower exposure to oxycodone compared to
oxycodone IR and crushed OxyContin. Peak oxycodone
concentrations (Cmax) were at least 4-fold lower for REMOXY,
microwaved or intact, compared to crushed OxyContin or oxycodone
IR. Additionally, time to reach peak oxycodone concentrations
was 3.5 times as long for REMOXY compared to crushed OxyContin.
The Cmax values for nasally administered REMOXY, microwaved
REMOXY, crushed OxyContin and oxycodone IR were 14.9, 11.9, 63.6
and 64.7 ng/ml, respectively. Tmax values were 3.1, 3.1, 0.88
and 1.6 hours, respectively.Finally, the Abuse Quotient
(AQ=Cmax/Tmax) is an essential measurement of abuse potential, with
lower scores suggesting comparatively lower potential for
abuse.
In this study, AQ measurements
were: <5.0
for REMOXY, intact or
microwaved 72.3
for OxyContin
crushed 40.4
for oxycodone IR
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 to make oxycodone difficult to abuse yet provide 12 hours of
steady pain relief when used appropriately by patients. In
particular, REMOXY’s thick, sticky, high-viscosity gel-cap
formulation may deter unapproved routes of drug administration,
such as injection, snorting or smoking.
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. Drug 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.
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.
Our pipeline of drug assets includes:
REMOXY ER (extended-release
oxycodone capsules CII) – Proprietary abuse-deterrent, twice-daily
oral oxycodone for severe chronic pain. NDA resubmission
planned for Q1 2018.
FENROCK™ (transdermal fentanyl
patch system) – Proprietary, abuse-deterrent skin patch for severe
pain. Early-stage program, substantially funded by a research
grant award from National Institute on Drug Abuse (NIDA).
PTI-125 – Proprietary small
molecule drug for the treatment of Alzheimer’s disease. Phase
I clinical-stage program, substantially funded by a research grant
award from the National Institutes of Health (NIH).
PTI-125-DX – Blood-based
diagnostic/biomarker to detect Alzheimer’s disease.
Early-stage program, substantially funded by a research grant
award from the NIH.
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 planned
resubmission of the REMOXY NDA in a timely matter. 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 the ability to resubmit
the REMOXY NDA in Q1 2018. 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.IR@paintrials.com(512) 501-2485
Pain Therapeutics (NASDAQ:PTIE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pain Therapeutics (NASDAQ:PTIE)
Historical Stock Chart
From Apr 2023 to Apr 2024