Complete (100%) bioavailability after subcutaneous administration when compared with intravenous administration - Diuresis at 8 and 24 hours was equivalent to diuresis following standard intravenous administration - U.S. and EU regulatory filings anticipated in 2016 –
LEXINGTON, MA. – scPharmaceuticals, Inc. today announced positive results from its pharmacokinetic and pharmacodynamics phase 3 pivotal registration trial. The trial in patients with heart failure compared subcutaneous administration of a novel furosemide formulation with intravenous administration of furosemide USP (the commercial reference product). Furosemide is a diuretic; it induces urine output to reduce fluid overload (edema), a hallmark of heart failure. The trial results indicated that the subcutaneous administration of the novel furosemide formulation was as effective as the traditional intravenous administration in getting furosemide into the blood stream, and in achieving diuresis. The subcutaneous administration used a proprietary biphasic delivery profile. The reference treatment was commercial furosemide injection, USP administered intravenously in accordance with its prescribing information.
· 50% Less Fracture Rates with CERAMENT™ with Gentamicin
· 50% Less Infection Recurrence with CERAMENT™ with Gentamicin
· 313 Patients Total in All Groups with a Minimum of 1 Year Follow-Up
Lund, Sweden, (PRNEWSWIRE) October 6, 2015 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced new data from the Bone Infection Unit at the Nuffield Orthopaedic Centre (part of Oxford University Hospitals) as presented at the recent European Bone & Joint Infection Society (EBJIS) meeting. The study, a comparative evaluation of three local antibiotic delivery materials used as bone defect fillers after excision of chronic osteomyelitis, found CERAMENT™ with Gentamicin performed better in all primary outcomes; recurrence rate, fracture rate and wound leakage rate, despite a higher percentage of compromised Class B hosts. The three study groups encompassed a total of 313 patients each with a minimum 1- year follow-up. The group including CERAMENT™ with Gentamicin resulted in fifty percent less fractures, fifty percent less infection recurrences and fewer prolonged wound leaks as compared with the collagen or calcium sulfate products.
During its first year of operations, Vtesse advances lead program into late-stage, pivotal trial and launches www.theNPCstudy.com
- Goal is to establish a clear foundational data set on the safety and efficacy of VTS-270 for treatment of NPC
GAITHERSBURG, Md., Sept. 28, 2015 /PRNewswire/ -- Vtesse, Inc. today announced that the first three patients have been screened for inclusion in its pivotal Phase 2b/3 clinical trial with VTS-270 for treatment of Niemann-Pick Type C1 Disease (NPC). This clinical trial follows a Phase 1 study conducted by researchers at the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
CERAMENT™ with Gentamicin Shown to Decrease Recurrence of Infection and Increase Bone Formation
Lund, Sweden, (PRNEWSWIRE) September 24, 2015 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced the presentation of new clinical data with the Company’s platform bone void filler, CERAMENT™ with antibiotics which was presented at the 34th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) on September 10-12 in Lisboa, Portugal. CERAMENT™|G is the first CE-marked antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis and was prominently featured at EBJIS, a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists.
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