News Release
Mallinckrodt Pharmaceuticals to Unveil First Clinical Data on MNK-795, an Extended-Release Oxycodone and Acetaminophen Combination, at PAINWeek
Data describe a human abuse liability study, delivery profile and
efficacy of MNK-795
ST. LOUIS--(BUSINESS WIRE)--Aug. 28, 2013--
Mallinckrodt
(NYSE: MNK) announced today that the first clinical data on MNK-795 will
be presented at PAINWeek 2013, to be held September 4-7 in Las Vegas.
MNK-795 is an extended-release oral formulation of oxycodone and
acetaminophen that has been studied in clinical trials for the
management of moderate to severe acute pain where the use of an opioid
analgesic is appropriate. On July 29, Mallinckrodt announced that the
U.S. Food and Drug Administration (FDA) accepted for filing the New Drug
Application for MNK-795 and granted priority review.
The data to be presented include results from a human abuse liability
(HAL) study comparing certain abuse-related characteristics of intact
and tampered-with MNK-795 with that of intact and tampered-with Percocet®1
(an immediate-release oxycodone/acetaminophen formulation); single- and
multi-dose pharmacokinetic studies that characterize the drug release
profile with immediate- and extended- release components over the
12-hour dosing interval; and a study of the compound’s efficacy and
safety in an acute pain model.
“We are pleased to share the first results from our MNK-795 clinical
development program which, if approved, could be a critical milestone
for us as an independent specialty pharmaceuticals company,” said Mark
Trudeau, President and Chief Executive Officer of Mallinckrodt.
“Mallinckrodt’s investment in MNK-795 exemplifies our longstanding
commitment to provide medications for the treatment of patients with
acute pain.”
Currently, there are no extended-release oxycodone/acetaminophen
combinations on the market for acute pain. In clinical trials, MNK-795
has been studied as two tablets dosed every 12 hours. The dosage form
was designed using technology with both immediate- and extended-release
components and potentially tamper-resistant properties.
In all, 15 abstracts for MNK-795 will be presented, including the
following:
Human Abuse Liability/tamper resistance abstracts
-
Comparison of Subjective Drug Effects of Orally Administered MNK-795
Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) Versus
Immediate-Release Oxycodone/Acetaminophen Tablets in Recreational
Users of Prescription Opioids
-
Evaluation of the Tamper-Resistant Properties of MNK-795
Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets
-
Relationship Between Oxycodone Pharmacokinetics and Subjective Drug
Effects Following Oral Administration of an Immediate-Release
Combination of Oxycodone and Acetaminophen and MNK-795
Controlled-Release Oxycodone/Acetaminophen (CR OC/APAP) Tablets
Pharmacokinetic abstracts
-
Comparison of the Pharmacokinetic Profile of a Single Dose of MNK-795,
a Controlled-Release Oxycodone and Acetaminophen Combination Tablet
(CR OC/APAP) and Marketed Immediate-Release Opioids and
Opioid/Acetaminophen Combination Tablets
-
Comparison of the Pharmacokinetic Profile of MNK-795, a New Oral,
Controlled-Release Formulation of Oxycodone/Acetaminophen (CR OC/APAP)
Analgesic at Steady State Versus Marketed Immediate-Release Tablets
-
Single Dose Pharmacokinetics of 1 and 2 Tablets of MNK-795
Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP)
Compared with Immediate-Release Oxycodone and Acetaminophen
-
Steady-State Pharmacokinetics of 1 and 2 Tablets of MNK-795, a
Controlled-Release Oxycodone and Acetaminophen (CR OC/APAP)
Combination, Compared with Immediate-Release Oxycodone and
Acetaminophen
-
Single-Dose Pharmacokinetics, Bioavailability, and Safety of MNK-795,
a Controlled-Release Oxycodone and Acetaminophen Combination Analgesic
(CR OC/APAP), Under Fed and Fasted Conditions
-
Half-Value Duration Analysis for Acetaminophen After Single and
Multiple Doses of Oral MNK-795 Controlled-Release
Oxycodone/Acetaminophen (CR OC/APAP) Tablets
-
Half-Value Duration Analysis for Oxycodone After Single and Multiple
Doses of Oral MNK-795 Controlled-Release Oxycodone/Acetaminophen (CR
OC/APAP) Tablets
-
Dose Proportionality and Linearity of Oxycodone After Single or
Multiple Oral Doses of MNK-795 Controlled-Release
Oxycodone/Acetaminophen (CR OC/APAP) Tablets
-
Dose Proportionality and Linearity of Acetaminophen After Single or
Multiple Oral Doses of MNK-795 Controlled-Release
Oxycodone/Acetaminophen (CR OC/APAP) Tablets
Efficacy and safety abstracts
-
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the
Safety and Analgesic Efficacy of MNK-795 Controlled-Release
Oxycodone/Acetaminophen Tablets (CR OC/APAP) in an Acute Pain Model
-
Open-Label Extension of a Randomized, Double-Blind,
Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy
of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR
OC/APAP) in an Acute Pain Model
-
Open-Label Safety of MNK-795, Controlled-Release
Oxycodone/Acetaminophen Tablets (CR OC/APAP) in Patients with
Osteoarthritis or Chronic Low Back Pain
About Mallinckrodt
Mallinckrodt is a leading global specialty pharmaceuticals business that
develops, manufactures, markets and distributes specialty pharmaceutical
products and medical imaging agents. The Company’s Specialty
Pharmaceuticals segment includes branded and generic drugs, and the
Global Medical Imaging segment includes contrast media and nuclear
imaging agents. Mallinckrodt has approximately 5,500 employees worldwide
with direct sales in roughly 50 countries and distribution in
approximately 40 countries. The Company’s 2012 revenue totaled $2.1
billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
FORWARD-LOOKING STATEMENTS
Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include, but are not limited to, statements
about future financial condition and operating results, economic,
business, competitive and/or regulatory factors affecting our business.
Any forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or Company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the U.S. Drug Enforcement
Administration, our ability to obtain and/or timely transport
molybdenum-99 to our technetium-99m generator production facilities,
customer concentration, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
our ability to successfully develop or commercialize new products, our
ability to protect intellectual property rights, competition, our
ability to integrate acquisitions of technology, products and
businesses, product liability losses and other litigation liability, the
reimbursement practices of a small number of large public or private
issuers, complex reporting and payment obligation under healthcare
rebate programs, changes in laws and regulations, conducting business
internationally, foreign exchange rates, material health, safety and
environmental liabilities, litigation and violations and information
technology infrastructure. These and other factors are identified and
described in more detail in the “Risk Factors” section of the Form 10
Registration Statement, as amended. We disclaim any obligation to update
these forward-looking statements other than as required by law.
1 Percocet is a registered trademark of Endo Pharmaceuticals
Inc.
Source: Mallinckrodt
Mallinckrodt
Lynn Phillips, 314-654-3263
Manager, Media
Relations
lynn.phillips@mallinckrodt.com
or
Meredith
Fischer, 314-654-6595
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com
or
John
Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com