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Share Name | Share Symbol | Market | Type |
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Mallinckrodt Plc | NYSE:MNK | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.75 | 0 | 01:00:00 |
STAINES-UPON-THAMES, United Kingdom, May 23, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 4 pilot study assessing the efficacy of H.P. Acthar® Gel (repository corticotropin injection) for the management of exacerbations of relapsing and remitting multiple sclerosis (RRMS) in patients whose relapse symptoms have not responded to a course of high-dose corticosteroids.
"Some MS patients may have relapse symptoms that don't resolve with steroid therapy, and in my experience, H.P. Acthar Gel may provide benefit in these cases," said Aaron Miller, M.D., a program advisor and participating site investigator from the Icahn School of Medicine at Mount Sinai in New York. "This study is an important step to confirming the appropriate patient type for this product as an approved and appropriate treatment for MS exacerbations."
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for treatment of acute exacerbations of multiple sclerosis in adults.
"Mallinckrodt is committed to providing alternative treatment options to patients who need them," said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President at Mallinckrodt. "Clinical experience and current labeling support the use of Acthar to speed recovery from relapses in MS. We are pleased to enroll the first patient in the OPTIONS trial to better understand the patients who will benefit from Acthar therapy, and to support its role in the management of RRMS."
About the OPTIONS Trial
The Phase 4 clinical study is titled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects With Relapsing-Remitting Multiple Sclerosis". The study will enroll patients with MS relapses of moderate severity and symptoms that have not adequately improved following a typical course of high dose IV or oral corticosteroid therapy, then randomize them to receive additional treatment with H.P. Acthar Gel or placebo in blinded fashion.
Improvement in relapse symptoms will be assessed using several standard MS disease activity measures, including the Expanded Disability Status Scale (EDSS), MS Impact Scale (MSIS-29), and Clinical Global Impressions-Improvement Scale (CGI-I). Because this trial targets only a subset of RRMS patients experiencing relapses who have not responded acutely to corticosteroid therapy, the study may take a number of years to recruit.
Find more information about the OPTIONS trial here on the ClinicalTrials.gov website.
About MS
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).1 Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes. More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.2
About H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of H.P. Acthar Gel use is in these indications:
For more information about Acthar, please visit www.acthar.com. Full Prescribing Information may be accessed here.
Important Safety Information
Please see full Prescribing Information here for additional Important Safety Information.
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; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CONTACTS
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
1 Multiple Sclerosis Foundation. Symptoms of Multiple Sclerosis. Accessed April 19, 2016 at http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx
2 National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Accessed April 19, 2016 at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/first-patient-enrolled-in-mallinckrodt-phase-4-trial-of-hp-acthar-gel-repository-corticotropin-injection-for-multiple-sclerosis-relapse-300462643.html
SOURCE Mallinckrodt Pharmaceuticals
Copyright 2017 PR Newswire
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