Remoxy Meets Primary Endpoint in Pivotal Phase III Study
- Pain Therapeutics Expected to File NDA Q2 2008 -
SAN MATEO, Calif. and BRISTOL, Tenn. – December 6, 2007
– Pain Therapeutics, Inc. (NASDAQ: PTIE) and King
Pharmaceuticals, Inc. (NYSE: KG) are pleased to announce positive
results of a Phase III study of Remoxy in patients with chronic
pain. Over 400 patients with osteoarthritis participated in this
pivotal study. The study met the primary endpoint (p<0.01) that
was prospectively defined by the U.S. Food and Drug Administration
(FDA) during the Special Protocol Assessment process.
Remoxy, an investigational drug, is an abuse-deterrent version of
long-acting oxycodone, a powerful painkiller available only by
prescription. Remoxy is intended to meet the needs of physicians or
pharmacists who appropriately prescribe or dispense long-acting
oxycodone and who seek to minimize the risks of abuse, misuse or
diversion.
The FDA has agreed in writing that a single Phase III pivotal study
is needed to support the regulatory approval of Remoxy. As a
result, Pain Therapeutics expects to file a New Drug Application
for Remoxy in Q2 2008. If approved, Remoxy will be the first
oxycodone on the market that is specifically designed to deter
common methods of abuse.
“Preserving the safety and integrity of prescription drugs is
always the right choice,” said Remi Barbier, Pain
Therapeutics’ Chairman, President and Chief Executive
Officer. “We pioneered the development of abuse-deterrent
opioids to raise the bar on drug safety to a new level. We believe
prescription drugs that minimize the risks of abuse, misuse or
diversion can deliver peace of mind to physicians, pharmacists and
patients in pain.”
Brian A. Markison, Chairman, President and CEO of King
Pharmaceuticals, stated, “Opioid analgesics play a very
important role in the effective management of moderate-to-severe
pain. However, abuse and misuse of these medicines represents a
major area of concern among healthcare professionals and
patients.” Mr. Markison explained, “Data show that over
12 million Americans used prescription pain relievers for
non-medical use in 2006, including approximately four percent of
high school seniors.”
Mr. Markison concluded, “We are addressing this alarming
public health issue by developing pain medicines that incorporate
safe and appropriate means to discourage abuse and misuse. The
successful completion of the pivotal Phase III study for Remoxy is
particularly exciting, as it is the first of several
abuse-deterrent opioid pain products which we plan to develop that
are formulated to deter the inappropriate use of these
drugs.”
Design of the Remoxy Phase III Study
This pivotal Phase III randomized, double-blinded,
placebo-controlled, multi-center study was designed to evaluate the
analgesic efficacy of twice-daily Remoxy versus placebo over a 12-
week treatment period. The study randomized 412 male and female
patients. All patients were diagnosed with osteoarthritis of the
knee or hip, as evidenced by x-ray and clinical criteria of the
American College of Rheumatology. Additionally, all patients had
pain intensity scores corresponding to moderate-to-severe
pain.
Following informed consent, wash-out and dose titration, patients
were randomized (1:1) into a double-blinded treatment period (12
weeks). During treatment, patients received twice-daily Remoxy or
matching placebo. The total drug dose per patient per day ranged
from 10-80mg. Pain intensity scores were assessed on a Likert pain
scale. Concomitant pain medications or rescue medications were not
allowed at any point during the 12-week treatment period. This
Remoxy study received a Special Protocol Assessment (SPA) from the
FDA. With an SPA,
the study design, endpoints and statistical analyses needed to
support approval were agreed upon by the FDA prior to initiating
the study and are considered binding.
Results of the Remoxy Phase III Study
Pursuant to an SPA, the primary endpoint was defined as mean
decrease in pain intensity scores between Remoxy and placebo during
the 12-week treatment period. Top-line data indicates that the
study achieved a statistically significant result in its primary
endpoint (p<0.01). In addition, the study achieved statistically
significant results in secondary endpoints such as Quality of
Analgesia (p<0.01) and Global Assessment (p<0.01). No
drug-related safety issues were noted in this study.
Conference Call With Dr. Lynn Webster, Principal Investigator
Pain Therapeutics’ management will host a conference call
today with guest speaker Lynn R. Webster, MD, Medical Director,
Lifetree Clinical Research & Pain Clinic, board certified in
anesthesiology and pain management and addiction medicine.
The conference call will be today at 10:00 a.m. Eastern Time/7:00
a.m. Pacific Time. To participate, please dial 866-578-5784 (within
the US) or 617-213-8056 (outside the US) fifteen minutes prior to
the start of the call. The pass code is 6955-1199. A replay will
also be available. To access the replay, please dial 888-286-8010
(within the U.S.) or 617-801-6888 (outside the U.S.) and enter pass
code 37411813. A web cast of the conference call will also be
available online at www.paintrials.com.
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration’s
website for more information:
http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm
About the Alliance Between King Pharmaceuticals and Pain
Therapeutics
In 2005, King and Pain Therapeutics entered into a strategic
alliance to develop and commercialize Remoxy and other opioid
painkillers designed to deter common methods of abuse. Pain
Therapeutics is substantially responsible for drug formulation,
clinical development and regulatory filings for Remoxy and other
opioid painkillers developed under this alliance.
Upon regulatory approval, King will assume sole control and
worldwide responsibility to exclusively commercialize Remoxy and
the other opioid drugs that are part of the alliance. Remoxy and
other opioid painkillers developed under this alliance are unique
formulations of the patented Oradur™ platform technology
licensed from Durect Corporation (NASDAQ: DRRX).
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops
novel drugs. We have four drug candidates in clinical programs,
including Remoxy, Oxytrex™, PTI-202 and a novel radiolabeled
monoclonal antibody to treat metastatic melanoma. We are also
working on a new treatment for patients with hemophilia. The FDA
has not yet evaluated the merits, safety or efficacy of our drug
candidates. For more information, please visit www.paintrials.com.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically
integrated branded pharmaceutical company. King, an S&P 500
Index company, seeks to capitalize on opportunities in the
pharmaceutical industry through the development, including through
in-licensing arrangements and acquisitions, of novel branded
prescription pharmaceutical products in attractive markets and the
strategic acquisition of branded products that can benefit from
focused promotion and marketing and product life-cycle
management.
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, Inc. and King
Pharmaceuticals, Inc. disclaim any intent or obligation to update
these forward-looking statements, and claim the protection of the
Safe Harbor for forward-looking statements contained in the Act.
Examples of such statements include, but are not limited to, any
statements relating to the timing of the expected filing of a New
Drug Application for Remoxy with the U.S. Food and Drug
Administration in 2008, the Companies’ plans to develop a
series of abuse-deterrent opioid pain products and the potential
benefits of the Companies’ drug candidates. 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 difficulties
or delays in development, testing, regulatory approval, production
and marketing of the Companies’ drug candidates, unexpected
delays in the companies’ filing of a New Drug Application for
Remoxy with the FDA, unexpected adverse sideeffects or inadequate
therapeutic efficacy of the Companies’ drug candidates that
could slow or prevent product approval or market acceptance
(including the risk that current and past results of clinical
trials are not necessarily indicative of future results of clinical
trials), the uncertainty of patent protection for the
Companies’ intellectual property or trade secrets, the
Companies’ ability to obtain additional financing if
necessary and unanticipated research and development and other
costs. For further information regarding these and other risks
related to the Companies’ business, investors should consult
the Companies’ filings with the U.S. Securities and Exchange
Commission.
For More Information Contact:
Pain Therapeutics, Inc.
Christi Waarich
Senior Manager of Investor Relations
650-645-1924
King Pharmaceuticals, Inc.
James E. Green David E. Robinson
Executive Vice President, Corporate Affairs Senior Director,
Corporate Affairs
423-989-8125 423-989-7045
Posted: December 2007
