Pain Therapeutics, Inc. (Nasdaq: PTIE) and King
Pharmaceuticals, Inc. (NYSE: KG) announced today the initiation of a Phase
I clinical trial to evaluate the effects of PTI-202 in humans. PTI-202 is a
new drug candidate in the companies' collaboration to develop
abuse-resistant opioid painkillers, a new category of drugs intended to
prevent prescription drug abuse.
In November 2005, Pain Therapeutics and King Pharmaceuticals announced
a broad strategic alliance to develop and commercialize four proprietary
lead drug candidates. All four drug candidates are intended to be
long-acting, abuse-resistant opioid painkillers. Two of these drug
candidates are now in clinical testing:
Drug Name: Remoxy(TM)
Description: Abuse-resistant oxycodone
Clinical Status: Phase III
Drug Name: PTI-202
Description: Abuse-resistant opioid (undisclosed)
Clinical Status: Phase I
PTI-202 is a long-acting opioid painkiller. Pain Therapeutics and King
Pharmaceuticals have not yet disclosed the active pharmaceutical drug in
PTI-202.
Pain Therapeutics recently submitted an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration (FDA) for PTI-202. FDA
acceptance of this IND triggered the payment of a $5 million cash milestone
from King Pharmaceuticals to Pain Therapeutics.
About Remoxy
Remoxy is being developed as an abuse-resistant version of long-acting
oxycodone. Its Phase III program remains on-track with previous guidance.
Remoxy is intended to meet the needs of physicians who appropriately
prescribe opioid painkillers and who seek to minimize risks of drug
diversion, abuse or accidental patient misuse. Remoxy has a sticky,
high-viscosity mass that resists injection or snorting. Published data show
that freezing, crushing or submerging Remoxy in high-proof alcohol for
hours at a time releases just a fraction of oxycodone compared to
Oxycontin(R) at time points when abusers presumably expect to get high.
Pain Therapeutics and King Pharmaceuticals believe these and other physical
properties of Remoxy may deter recreational abuse or accidental patient
misuse of long acting oxycodone.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel
drugs. We have three investigational drug candidates in clinical programs.
Remoxy and PTI-202 are proprietary, abuse-resistant forms of currently
prescribed opioid drugs. Oxytrex(TM) is a novel, next-generation painkiller
that potentially offers less physical dependence than currently marketed
opioid painkillers. These three drugs target different segments of the
multi-billion dollar market to treat severe chronic pain, such as
persistent low-back pain or pain due to advanced stages of osteoarthritis.
The FDA has not yet evaluated the merits, safety or efficacy of our drug
candidates. For more information, please consult our website:
paintrials.
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.
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,
any statements relating to the timing of the completion of the Pain
Therapeutics' (the "Company") Phase I clinical trial for PTI-202 and
announcement of results from such clinical trial, the Company's guidance
with respect to the clinical trials program for Remoxy, and the potential
benefits of the Company's 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 Company's drug candidates, unexpected
adverse side effects or inadequate therapeutic efficacy of the Company's
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), and the uncertainty of patent protection for the Company's
intellectual property or trade secrets. For further information regarding
these and other risks related to Pain Therapeutics' business, investors
should consult the Company's filings with the Securities and Exchange
Commission.
Pain Therapeutics, Inc.
paintrials
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