Mallinckrodt's SpecGx LLC Reports on Outcome of FDA Joint Advisory Committee on Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride)

-- Committees Vote to Approve Drug with Abuse-Deterrent Labeling --

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Nov 14, 2018, 17:08 ET

ST. LOUIS, Nov. 14, 2018 /PRNewswire/ -- SpecGx LLC (SpecGx), a subsidiary of Mallinckrodt plc (NYSE: MNK) that operates its Specialty Generics business, today announced that, in a joint meeting, the U.S. Food and Drug Administration's (FDA's) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve the SpecGx investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Additionally, the Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse.

The Committees also voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.

SpecGx is advancing this reformulation of Roxicodone^® (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application MNK-812. The company has been a leader for a number of years in delivering important solutions, including development of this technology, to reduce opioid misuse, abuse and diversion.

"We appreciate the Committees' thoughtful review and discussion of the potential benefits our new abuse-deterrent formulation drug can bring in helping to mitigate opioid abuse and misuse," said Matt Harbaugh, Executive Vice President, Chief Financial Officer and President, Specialty Generics. "We are encouraged by the positive feedback, and will work closely with the FDA to address any questions the Agency may have."

The role of the Committees is to provide recommendations to the FDA, though the recommendations are not binding.

The company has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multi-pronged program to address opioid abuse. In addition to abuse-deterrent technology, those efforts include the purchase and donation of nearly two million drug disposal pouches, and working with policymakers, community leaders, law enforcement and industry partners to ensure the responsible use of pain medication and preventing unused medications from ending up in the wrong hands. These efforts will continue to be supported.

Please click here for more information about these efforts.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Included within the company's discontinued operations, the Specialty Generics business includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning MNK-812 including expectations with regard to future regulatory actions and potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; future commercialization efforts; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

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Rhonda Sciarra
Senior Communications Manager
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Meredith Fischer
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Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
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SOURCE Mallinckrodt plc