Newsroom

Mallinckrodt Pharmaceuticals Reports Human Abuse Liability (HAL) Data for MNK-795, an Extended-Release Oxycodone/Acetaminophen Combination

HAL study compares abuse-related characteristics of MNK-795 with Percocet^®

LAS VEGAS--(BUSINESS WIRE)--Sep. 4, 2013-- Mallinckrodt (NYSE: MNK) today reported data from a Human Abuse Liability (HAL) study comparing certain abuse-related characteristics of MNK-795 with those of Percocet (an immediate-release oxycodone/acetaminophen formulation). In the HAL study, intact and crushed MNK-795 had statistically significant (p <0.001) lower measures of drug liking, drug high, and good drug effects than comparable doses of Percocet when measured at the peak drug effect (E_max). The data are being presented at PAINWeek, a national conference on pain for frontline practitioners, taking place in Las Vegas September 4-7, 2013.

MNK-795 is an investigational, extended-release, oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. In July, the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for MNK-795 and granted priority review.

The problems of potential misuse and abuse of opioid pain medications are a key focus for the FDA with regard to evaluation of new medications for potential use in pain management. Included in the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling (January 2013), HAL studies are relatively new for investigational pain medications. These studies are an important tool for the FDA to assess the relative abuse potential of a new drug. For drugs with abuse-deterrent properties, a HAL study assesses the impact of the potentially abuse-deterrent formulation on measures that predict how probable it is that the medication will be attractive to abusers. The industry guidance recommends that a Visual Analog Scale (VAS) be used to measure drug liking, drug high, good drug effects, and other qualities, as it appears to correlate most directly with potential for abuse.

“These results are significant in the field of acute pain management, as MNK-795 is the first oxycodone/acetaminophen combination reported to meet all three of these endpoints (drug liking, drug high, and good drug effects) in a human abuse liability or HAL study,” said Lynn Webster, M.D., co-founder and chief medical director of Lifetree Clinical Research^®, who led the study. “Oxycodone and acetaminophen combinations are widely used for managing acute pain, but are commonly abused. There is a real need for improved formulations that address patient and physician concerns about these kinds of medications.”

HAL Study Details

The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, 7-way crossover study assessing the abuse potential of MNK-795 in 55 healthy male and female non-dependent recreational opioid users. During the seven treatment periods, subjects received a single treatment with one of the seven study drugs:

• Placebo
• 15 mg/650 mg MNK-795 (low dose, intact)
• 15 mg/650 mg Percocet (low dose, intact)
• 30 mg/1300mg MNK-795 (high dose, intact)
• 30 mg/1300mg Percocet (high dose, intact)
• Crushed, encapsulated high dose MNK-795
• Crushed, encapsulated high dose Percocet

The study evaluated the subjective effects that have been associated with drug abuse. The primary outcome measures were 100-point VAS of subject-reported drug liking, drug high, and good drug effects. The most common adverse events associated with the use of MNK-795 included nausea, vomiting, and pruritus (itching).

Percocet is a registered trademark of Endo Pharmaceuticals Inc.

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 other 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.

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