Mallinckrodt Pharmaceutical’s MNK-155, an Extended-Release Hydrocodone/Acetaminophen Combination, Shows Efficacy in Phase 3

  Mallinckrodt Pharmaceutical’s MNK-155, an Extended-Release
  Hydrocodone/Acetaminophen Combination, Shows Efficacy in Phase 3 Acute Pain

  MNK-155 (hydrocodone bitartrate/acetaminophen) demonstrated significantly
         greater pain reduction than placebo following bunion surgery

PAINWeek 2014

Business Wire

LAS VEGAS -- September 4, 2014

Mallinckrodt (NYSE: MNK) today reported that a Phase 3 efficacy trial of
investigational MNK-155 met the study’s primary endpoint of improved pain
scores vs. placebo over the first 48 hours following bunionectomy (p<0.001).
This difference in pain scores was statistically significant in favor of
MNK-155. The data is being presented at PAINWeek 2014, a national conference
on pain for frontline practitioners, held in Las Vegas, Nevada September 2-6,

MNK-155 is an investigational extended-release oral formulation of hydrocodone
and acetaminophen being studied for the management of moderate to moderately
severe acute pain where the use of an opioid analgesic is appropriate. MNK-155
is formulated with both immediate- and extended-release components. The
release profile of MNK-155 combines Mallinckrodt-proprietary, patented
technology and Depomed’s advanced Acuform^® drug delivery technology. The NDA
for MNK-155 was accepted for review by the U.S. FDA in May 2014 and included
results from this study.

“In this study, MNK-155 showed rapid, significant and superior pain relief to
placebo with a 12-hour dosing interval throughout the 48-hour study period,”
said Dr. Mario Saltarelli, Chief Science Officer, Mallinckrodt
Pharmaceuticals. “These positive Phase 3 findings are great news as we strive
to develop new medications with less frequent dosing for patients with acute

In addition to the Phase 3 study, Mallinckrodt will present data at PAINWeek
from several other MNK-155 trials, including the pharmacokinetics, safety and
subjective effects of abuse-related characteristics.

Study Details

The Phase 3 trial was a multicenter, randomized, double-blind,
placebo-controlled, parallel-arm study comparing the efficacy and safety of
MNK-155 and placebo in 403 patients with moderate to moderately severe acute
pain following a unilateral first metatarsal bunionectomy. Subjects received a
single 3-tablet loading dose of MNK-155 (7.5 mg hydrocodone and 325 mg
acetaminophen tablets; 22.5 mg/975 mg total dose), followed by 2 tablets every
12 hours (15 mg /650 mg total dose) over 48 hours or placebo. Rescue ibuprofen
up to 400 mg every 4 hours was allowed for both the MNK-155 and placebo arms.

The primary endpoint was the summed pain intensity difference (change in pain
from baseline) over 48 hours (SPID48). Secondary measures included: Cumulative
SPID at 0−4, 0−8, 0−12, 0−24, and 0−36 hours; mean PID beginning 15 minutes
after dosing, mean total pain relief (TOTPAR) for the time periods 0−4, 0−8,
0−12, 0−24, 0−36, and 0−48 hours; and time to perceptible, confirmed, and
meaningful pain relief. The most common adverse events associated with the use
of MNK-155 were nausea, dizziness, vomiting, headaches, constipation, pruritus
and somnolence (sleepiness).

About Mallinckrodt

Mallinckrodt is a global specialty pharmaceutical and medical imaging business
that develops, manufactures, markets and distributes specialty pharmaceutical
products and medical imaging agents. Areas of focus include analgesics and
central nervous system drugs for prescribing by office- and hospital-based
physicians, and autoimmune and rare disease specialty areas like neurology,
rheumatology, nephrology and pulmonology. The company's core strengths include
the acquisition and management of highly regulated raw materials; deep
regulatory expertise; and specialized chemistry, formulation and manufacturing
capabilities. The company's Specialty Pharmaceuticals segment includes branded
and specialty generic drugs and active pharmaceutical ingredients, and the
Global Medical Imaging segment includes contrast media and nuclear imaging
agents. Mallinckrodt has more than 5,500 employees worldwide and a commercial
presence in roughly 65 countries. The company's fiscal 2013 revenue totaled
$2.2 billion. To learn more about Mallinckrodt, visit


Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-6595
Senior Vice President, Communications
John Moten, 314-654-6650
Vice President, Investor Relations
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