STAINES-UPON-THAMES, United Kingdom, May 25, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, highlights the first patients enrolled in an ongoing company-sponsored study on the use of H.P. Acthar® Gel (repository corticotropin injection) following acute multiple sclerosis (MS) relapse. The prospective observational registry will contribute to the understanding of the type of MS patient receiving H.P. Acthar Gel for a relapse and the impact of this treatment. The study will also assess patient reported outcomes from patients who receive H.P. Acthar Gel regarding treatment patterns, MS relapse recovery and safety outcomes. Preliminary demographic data will be presented on Thursday, May 25 at the 2017 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in New Orleans, La.
"Despite advances in the management of MS, many patients still experience relapse, and an incomplete recovery from relapse may contribute to continued accrual of disability for diagnosed patients1,2,3," said Tunde Otulana, Chief Medical Officer at Mallinckrodt. "Mallinckrodt is committed to conducting studies in MS relapse patients treated with Acthar to collect valuable information about their treatment patterns, MS relapse recovery and safety outcomes."
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for treatment of acute
exacerbations of MS in adults.
A Prospective Observational Registry of H.P. Acthar Gel for the Treatment of Multiple Sclerosis Relapse is enrolling patients and collecting demographic data to characterize the patient population who receive H.P. Acthar Gel to treat acute MS relapse. The study will describe treatment patterns, MS relapse recovery and safety outcomes. The goal is to enroll 260 patients at up to 60 study sites over 24 months. Patients who have experienced a relapse are clinically evaluated with the MS Impact Scale, version 1 (MSIS-29v1), Expanded Disability Status Scale (EDSS), Functional System Score, and Clinical Global Impression of Improvement scale at baseline, two months, and six months following their clinical episode. Patients are also evaluated with health outcomes assessments, including the healthcare resource utilization and Work Productivity and Activity Impairment questionnaires.
Preliminary data on 45 patients (enrolled as of October 27, 2016) found:
Find more information about the observational registry here on the ClinicalTrials.gov website.
The poster is available on the Mallinckrodt website.
ABOUT MULTIPLE SCLEROSIS (MS)
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).7 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.8
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 Acthar use is in these indications:
For more information about Acthar, please visit www.acthar.com. The 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 Confavreux C, Vukusic S, Moreau T, Adeleine P. Relapses and progression of disability in multiple sclerosis. New England Journal of Medicine, 2000, Nov 16;343(20):1430-8. Available at: https://www.ncbi.nlm.nih.gov/pubmed/11078767. Accessed May 23, 2017.
2 Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain. 2003 Apr; 126(Pt 4):770-82. Available at: https://www.ncbi.nlm.nih.gov/pubmed/12615637. Accessed May 23, 2017.
3 Hirst C, Ingram G, Pearson O, Pickersgill T, Scolding N, Robertson N. Contribution of relapses to disability in multiple sclerosis. Journal of Neurology. 2008 Feb;255(2):280-7.
4 Data available for 36 patients.
5 Data available for 27 patients, rated on a scale from 0 (normal neurologic exam) to 10 (death due to MS).
6 Data available for 35 patients, scored on a scale of 0 to 100, with 100 representing worst possible score.
7 Multiple Sclerosis Foundation. Symptoms of Multiple Sclerosis. Available at: http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx. Accessed April 19, 2017.
8 National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Available at: http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Accessed April 21, 2017.
SOURCE Mallinckrodt plc