STAINES-UPON-THAMES, United Kingdom, Dec. 4, 2017
STAINES-UPON-THAMES, United Kingdom, Dec. 4, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, announced results from a retrospective, claims-based analysis providing health economic insights on the use of medication and healthcare resource utilization (HCRU) among patients with infantile spasms in the 90 days prior to receipt of H.P. Acthar® Gel (repository corticotropin injection) therapy. The findings were presented in a poster session at the American Epilepsy Society Annual Meeting, held Dec. 1-5, in Washington, D.C.
"This analysis showed a substantial healthcare burden among all patients with infantile spasms prior to initiation of H.P. Acthar Gel therapy, suggesting a delay in diagnosis or the possible presence of complex seizure types, as well as a delay in receipt of appropriate therapy," said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. "Children who develop infantile spasms are at great risk for seizures, autism spectrum disorders, and developmental delays.1 Therefore, gaining insight into real-world treatment patterns leading up to the use of approved therapy is critical."
Infantile spasms is a rare condition that is often difficult to recognize,2 even by physicians. Symptoms may appear similar to other common disorders, which may adversely impact time to diagnosis, receipt of approved therapy and health outcomes.2 H.P. Acthar Gel is a first-line monotherapy indicated for the treatment of infantile spasms in infants and children under two years of age.3 Please see Important Safety Information below.
The intended audiences of the study below are population-based decision makers with knowledge and expertise in the area of health care economic analysis and its limitations.
Medication Utilization Patterns Prior to Use of Repository Corticotropin Injection in Patients with Infantile Spasms (AES# 3.279)
Key study highlights include:
"This analysis provides new insights into the impact of potential delays in diagnosis and management of infantile spasms," said Laura Gold, PhD, Primary Investigator and lead author of the study. "These findings underscore the considerable healthcare burden placed on patients with infantile spasms, their caregivers, and the healthcare system."
Mallinckrodt sponsored the study, which was conducted by researchers from the University of Washington and Mallinckrodt. The poster with additional study details is available on the Mallinckrodt website.
ABOUT INFANTILE SPASMS
Infantile spasms, sometimes called West syndrome, is a rare seizure disorder that occurs in approximately 2,000 to 2,500 infants per year in the U.S., based on a review of population-based studies of the condition.5 It most commonly occurs between four and eight months of age.6 Early identification, diagnosis, and treatment of infantile spasms are essential to help limit lasting effects.2 Children with infantile spasms generally have one or more of the following symptoms: a certain type of seizure (called "spasms"), a disorganized and chaotic brain-wave pattern called hypsarrhythmia as recorded on an EEG (electroencephalogram), or a failure to meet developmental milestones.7
H.P. Acthar Gel (repository corticotropin injection) Indications
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:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
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.
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2017 Mallinckrodt ARDUS/01-02/1117/0048 12/17
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* Sabril®, a registered trademark of Lundbeck, is FDA-approved for the treatment of infantile spasms in infants one month to two years of age.
1 Gold LS, Schepman PB, Wang WJ, et al. Healthcare costs and resource utilization in patients with infantile spasms treated with H.P. Acthar Gel®. Adv Ther. 2016; 33:1293-1304.
2 Child Neurology Foundation. Disorder Directory: Learn from the Experts. Infantile Spasms. http://www.childneurologyfoundation.org/disorders/infantile-spasms/. Accessed November 15, 2017.
3 H.P. Acthar Gel® (repository corticotropin injection) [package insert]. Hazelwood, MO: Mallinckrodt Pharmaceuticals; 2015. http://www.acthar.com/pdf/acthar-pi.pdf. Accessed November 28, 2017.
4 Sabril® (vigabatrin) [package insert]. Deerfield, IL: Lundbeck; 2017. http://www.lundbeck.com/upload/us/files/pdf/Products/Sabril_PI_US_EN.pdf. Accessed on November 28, 2017.
5 Wheless J, Gibson P, Rosbeck K, et al. Infantile spasms (West syndrome): update and resources for pediatricians and providers to share with parents. BMC Pediatrics. 2012;12(1):108. doi:10.1186/1471-2431-12-108. Accessed August 28, 2017.
6 Hrachovy R. West's syndrome (infantile spasms). Clinical description and diagnosis. Adv Exp Med Biol. 2002;497:33-50.
7 Go CY, Mackay MT, Weiss SK, et al. Evidence-based guideline update: medical treatment of infantile spasms. Neurology. 2012;78:1974-1980.
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SOURCE Mallinckrodt plc
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