- Study Meets Primary Endpoint (p<0.01) -
- REMOXY NDA Remains On-Track for Resubmission in Q1 2018 -
AUSTIN, Texas, Jan. 09, 2018 (GLOBE NEWSWIRE) -- 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 Abuse
Opioid 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 Araya
Pain Therapeutics, Inc.
IR@paintrials.com
(512) 501-2485
