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https://www.biopharmadive.com/news/shires-new-elaprase-formulation-fails-late-stage-trial/513429/
Dec 19, 2017 · Shire's new formulation, known as SHP609 or HGT-2310, is largely the same, only it's administered directly into a patient's cerebrospinal fluid through an intrathecal drug delivery device. After a year of monthly treatments, participants in the trial's experimental arm didn't show significant improvement in cognition compared to control groups, according to topline results released Tuesday.
https://www.shiretrials.com/en/studies/clinicaltrialsen/2018/12/11/10/08/shp611-201
The study will consist of a screening period of up to 28 days. All participants will receive a once weekly dose of intrathecal (IT) SHP611 at 150 mg for 105 weeks via an intrathecal drug delivery device (IDDD) that will be implanted during a period of up to 10 days before the first administration of IT SHP611.
https://www.fiercepharma.com/drug-delivery/shire-s-intrathecally-delivered-candidate-for-hunter-syndrome-gets-fda-s-fast-track
Jan 27, 2015 · Rare disease specialist Shire announced today that it has received Fast Track Designation from the FDA for a reformulated, intrathecally delivered version of its successful drug …
https://mldfoundation.org/research-shire.php
Study Summary – Every other week intrathecal injections for 38 weeks via an intrathecal drug delivery device (IDDD) or port implanted in the patient's abdomen. Cohorts – The study will be performed with 18 patients divided into three cohorts of six patients each at increasing dosages of HGT-1110; 10, 30 & 100 mg at each infusion.
https://www.shire.com/~/media/shire/shireglobal/shirecom/pdffiles/newsroom/2015/january/20150126-fast-track-press-release.pdf?la=en
Jan 26, 2015 · fluid via an intrathecal drug delivery device * (IDDD). This formulation is being investigated and developed for use with Shire’s currently approved t reatment for Hunter syndrome, ELAPRASE® (idursulfase). ELAPRASEis administered intravenously and does not cross the blood-brain barrier in clinically relevant amounts.
http://investors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/content-pdf/07-shire-mayer-cns.pdf
intrathecal drug delivery device (IDDD) • Soph-A-Port ® Mini S is an implantable access system designed to provide repeated access to the intrathecal space for drug delivery • It is CE marked in Europe and approved for investigational use in the US • It is. currently being used in Shire’s Hunter-IT, Sanfilippo A and MLD
https://www.sciencedirect.com/science/article/pii/S0169409X20300120
Intrathecal (IT) administration, i.e., the injection of substances directly into cerebrospinal fluid (CSF) that fills the thecal sac, is a potentially powerful drug delivery approach. This route of administration can achieve a high concentration of therapeutic agent within the central nervous system (CNS) while minimizing off-target exposure ...Author: M.J. Fowler, J.D. Cotter, B.E. Knight, E.M. Sevick-Muraca, D.I. Sandberg, D.I. Sandberg, R.W. Sirian...
https://www.globenewswire.com/news-release/2017/12/19/1266050/0/en/Shire-Announces-Top-Line-Results-for-Phase-II-III-Clinical-Trial-in-Children-with-Hunter-Syndrome-and-Cognitive-Impairment.html
Dec 19, 2017 · In clinical trials, SHP609 is administered to patients using an intrathecal drug delivery device. 7 SHP609 is administered directly into the cerebrospinal fluid as a means of delivering the drug ...Author: Shire Pharmaceuticals Group
https://www.medtronic.com/us-en/patients/treatments-therapies/drug-pump-chronic-pain.html
OVERVIEW TARGETED DRUG DELIVERY. Patients report a reduction in pain scores after receiving targeted drug delivery. 51% of patients completely eliminated other opioids* at 12 months. 1 87% of patients rated their quality of life as fair to excellent. 2 90% of patients would recommend therapy to a family member or friend. 2
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