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Pharma Industry / Biotech Industry News From Medical News Today
Prescription Drug Import Amendment Divides Senate Democrats
Wed, 16 Dec 2009 02:00:00 -0800
The Senate is battling over a proposed amendment that would allow prescription drugs to be imported from other countries where prices are lower...
Scientists Rediscover Gene Target For Cancer Therapy
Wed, 16 Dec 2009 01:00:00 -0800
Epeius Biotechnologies Corporation, an emerging leader in the field of targeted genetic medicine, gained international validation of the cutting-edge science behind its lead oncology product, Rexin-G, when scientists around the world rediscovered the Cyclin G1 gene to be a major locus of cancer pathogenesis and disease progression, and thus a prime target for anti-cancer therapies...
Sanofi Pasteur Expands Study Of Vaccine Against Clostridium Difficile Into The U.S
Wed, 16 Dec 2009 00:00:00 -0800
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that it is expanding its phase II clinical study of a vaccine against Clostridium difficile infection (CDI) into the United States. The trial started in the United Kingdom earlier this year. The incidence of CDI has increased significantly in recent years in both North America and Europe...
Jazz Pharmaceuticals Submits New Drug Application For JZP-6 (sodium Oxybate) For The Treatment Of Fibromyalgia
Wed, 16 Dec 2009 00:00:00 -0800
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. The submission is based on a comprehensive clinical development program for JZP-6, including results from two Phase III clinical trials...
Cardio3 BioSciences Completes Patient Enrolment In First Stage Of Pivotal Trial Of C-Cure(R) In Heart Failure
Wed, 16 Dec 2009 00:00:00 -0800
Cardio3 BioSciences, a leading Belgian biotechnology company specialising in cell-based therapies for the treatment of cardiovascular diseases, announced that it has completed, two months ahead of schedule, enrolment in the first stage of its pivotal Phase II/III trial of C-Cure, a unique stem cell therapy for heart failure...
Alexza Announces Submission Of AZ-004 (Staccato(R) Loxapine) NDA
Wed, 16 Dec 2009 00:00:00 -0800
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder...
Annals of Pharmacotherapy PAP Articles
Plerixafor for Stem Cell Mobilization in Patients with Non-Hodgkin's Lymphoma and Multiple Myeloma (January) (CE)
Choi, H.-Y., Yong, C.-S., Yoo, B. K. OBJECTIVE: To evaluate the literature characterizing the mechanism of action, pharmacokinetics, pharmacodynamics, and therapeutic efficacy of plerixafor for hematopoietic stem cell (HSC) mobilization for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma. DATA SOURCES: A PubMed search (1966-September 2009) was conducted using the key words plerixafor and AMD3100. Manufacturer's prescribing information was also used. STUDY SELECTION AND DATA EXTRACTION: English-language articles were selected and data were extracted with a focus on clinical studies of HSC mobilization in patients with NHL or multiple myeloma. DATA SYNTHESIS: Plerixafor exerts its effect by reversibly blocking the ability of HSC to bind to the bone marrow matrix. When used with granulocyte colony-stimulating factor (G-CSF), plerixafor helps increase the number of HSCs in the peripheral blood, where they can be collected for use in autologous transplantation. In clinical studies, plerixafor was rapidly absorbed after subcutaneous injection, reaching a maximum plasma concentration at approximately 0.5 hours. Plerixafor is renally excreted as the parent drug, with an elimination half-life ranging from 3 to 5 hours. Plerixafor increases circulating CD34+ cells in the peripheral blood, with a peak effect about 6-9 hours after subcutaneous administration. An approximate 2- to 3-fold increase in the CD34+ cell count is seen by the first dose of plerixafor after 4 consecutive days of G-CSF treatment. In 2 Phase 3 studies in patients with NHL or multiple myeloma, addition of plerixafor to G-CSF resulted in a higher CD34+ cell collection with fewer apheresis days, but failed to show better graft durability or overall patient survival for up to 12 months of follow-up. CONCLUSIONS: Clinical trials have demonstrated that the addition of plerixafor to G-CSF was beneficial for HSC mobilization to peripheral blood for collection and subsequent transplantation in patients with NHL or multiple myeloma. Further studies should assess the benefit of the additive use of plerixafor on clinical outcomes.
Clopidogrel Hypersensitivity: A Novel Multi-Day Outpatient Oral Desensitization Regimen(January)
Fajt, M., Petrov, A. BACKGROUND: Clopidogrel hypersensitivity has posed a problem for the acute treatment and long-term care of a particular patient population with coronary artery disease and stent placement. Patients with clopidogrel hypersensitivity have had an increased risk of hypersensitivity reactions, including anaphylaxis, if they ingest clopidogrel without undergoing an oral desensitization procedure. The previously published desensitization protocols have either been performed in the intensive care unit, requiring significant cost and healthcare utilization, or have required a full-day outpatient commitment on behalf of the patient. OBJECTIVE: To determine whether a multi-day outpatient oral clopidogrel desensitization protocol is effective and safe for patients with clopidogrel hypersensitivity. METHODS: We retrospectively assessed the efficacy of a 10-dose outpatient multi-day clopidogrel desensitization protocol performed in a university allergy-immunology center from April 2006 to October 2008 in patients with clopidogrel hypersensitivity. Patients were desensitized over 2-3 half-day clinical visits and were able to go home between desensitization sessions. A preliminary cost analysis was performed using the average of actual costs for the outpatient clopidogrel desensitization procedure and was compared with the average cost for an inpatient oral desensitization completed at our institution. RESULTS: Eight patients with coronary artery disease, cardiac stent placement, and clopidogrel hypersensitivity underwent an outpatient multi-day oral clopidogrel desensitization procedure. All patients were successfully desensitized with the multi-day protocol without complications. No patient had recurrence of allergic reaction 3 months after the procedure. A preliminary cost analysis demonstrated a lower cost for the outpatient compared to the inpatient oral clopidogrel desensitization protocol. CONCLUSIONS: This outpatient 10-dose multi-day clopidogrel desensitization protocol is a safe and effective novel approach for the treatment of clopidogrel hypersensitivity in patients with coronary artery disease and cardiac stent placement. In addition to safety and efficacy, this protocol offers the patient the convenience of avoiding hospital admission or full-day time commitments.
Cyclosporine Versus Tacrolimus in Immunosuppressive Maintenance Regimens in Renal Transplants in Brazil: Survival Analysis from 2000 to 2004 (January)
Guerra Jr, A. A., Cesar, C. C., Cherchiglia, M. L., Andrade, E. I. G., de Queiroz, O. V., Silva, G. D, de Assis Acurcio, F. BACKGROUND: In Brazil, the National Health System (SUS) is responsible for almost all renal transplants. SUS protocols recommend using cyclosporine, in association with azathioprine and corticosteroids, to maintain the immunosuppression that is essential for successful renal transplant. Alternatively, cyclosporine can be replaced by tacrolimus. OBJECTIVE: To evaluate the effectiveness of therapeutic schema involving cyclosporine or tacrolimus after renal transplant during a 60-month follow-up period. METHODS: A historical cohort study, from 2000 to 2004, was conducted using 5686 patients who underwent renal transplant and received cyclosporine or tacrolimus. Uni - and multivariate analyses were performed using the Cox model to examine factors associated with progression to treatment failure. RESULTS: Most of the patients were male, aged 38 years or older, for whom the most frequent primary diagnosis of chronic renal failure (CRF) was glomerulonephritis/ nephritis. Higher risk of treatment failure was associated with: therapeutic regimen (tacrolimus, HR 1.38, 95% CI 1.14 to 1.67), patient age at transplantation (additional year, HR 1.01, 95% CI 1.00 to 1.02), donor type (deceased, HR 1.60, 95% CI 1.35 to 1.89), median time of dialysis prior to transplantation (>24 mo, HR 1.29, 95% CI 1.09 to 1.52), and primary CRF diagnosis (diabetes, HR 1.54, 95% CI 1.09 to 2.17). CONCLUSIONS: The risk of treatment failure of patients receiving tacrolimus was observed to be 1.38 times that of those receiving cyclosporine, after adjusting the model for possible confounding factors such as patient sex, patient age, graft origin, prior time of dialysis, and cause of CRF. Our results were obtained from an observational study, and further studies are necessary to evaluate whether compliance with SUS clinical protocols could result in more effective care for renal transplant recipients.
A Clinical Review of Echinocandins in Pediatric Patients (January) (CE)
VandenBussche, H. L, Van Loo, D. A OBJECTIVE: To identify and evaluate available data on pediatric echinocandin use. DATA SOURCES: A PubMed search, limited to English-language articles, was conducted (1990-August 2009) using the search terms echinocandin, pediatric, child, pharmacokinetics, caspofungin, micafungin, and anidulafungin. Additional articles were retrieved from citations of selected references. STUDY SELECTION AND DATA EXTRACTION: Relevant information on the pharmacology, pharmacokinetics, efficacy, and safety of echinocandins in children was selected. Clinical trials, retrospective reviews, and case series were identified and evaluated. Data from these sources were included in this review. DATA SYNTHESIS: Caspofungin is the only echinocandin approved by the Food and Drug Administration for use in children. Pediatric pharmacokinetics has been evaluated with all 3 echinocandins but is limited with anidulafungin. Micafungin is the most well-studied agent in prospective clinical trials for antifungal prophylaxis in stem cell transplantation and treatment of invasive fungal infections. Caspofungin has been studied prospectively for febrile neutropenia and treatment of invasive fungal infections, but most published data are from retrospective reviews or case reports. One case report of anidulafungin for neonatal candidiasis has been published. The role of echinocandins in the management of invasive pediatric fungal infections has expanded. Micafungin and caspofungin are recommended as primary or alternative treatment of candidemia and esophageal or invasive candidiasis, and as salvage therapy for invasive aspergillosis. Micafungin is recommended for neutropenic prophylaxis in stem cell transplantation, while caspofungin may be used in febrile neutropenia as an alternative to azoles. Dosing has been well established for caspofungin only in children 3 months of age and above. Anidulafungin should be avoided in children until more pharmacokinetic and clinical data become available. CONCLUSIONS: Further comparative trials are needed to more clearly define the role of echinocandins, either as monotherapy or in combination for difficult-to-treat infections, in the pediatric population.
Books Received (January)
Mosby's Drug Reference for Health Professions, 2nd Edition (January)
Lynch, S. S
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds
In This Issue
Mon, 16 Nov 2009 00:00:00 -0000
In This Issue Clinical Pharmacology & Therapeutics 86, 571 (December 2009). doi:10.1038/clpt.2009.229
Neonatal Pharmacology: Rational Therapeutics for the Most Vulnerable
L JamesS Ito Mon, 16 Nov 2009 00:00:00 -0000
Neonatal Pharmacology: Rational Therapeutics for the Most Vulnerable Clinical Pharmacology & Therapeutics 86, 573 (December 2009). doi:10.1038/clpt.2009.212 Authors: L James & S Ito
Highlights
Mon, 16 Nov 2009 00:00:00 -0000
Highlights Clinical Pharmacology & Therapeutics 86, 578 (December 2009). doi:10.1038/clpt.2009.230 Author:
ASCPT News
Mon, 16 Nov 2009 00:00:00 -0000
ASCPT News Clinical Pharmacology & Therapeutics 86, 580 (December 2009). doi:10.1038/clpt.2009.220
Pediatric Drug Development: Concepts and Applications
S M MacLeod Mon, 16 Nov 2009 00:00:00 -0000
Pediatric Drug Development: Concepts and Applications Clinical Pharmacology & Therapeutics 86, 583 (December 2009). doi:10.1038/clpt.2009.192 Author: S M MacLeod
Clinical Trials in Neonates: A Therapeutic Imperative
R M WardS E Kern Mon, 16 Nov 2009 00:00:00 -0000
Clinical Trials in Neonates: A Therapeutic Imperative Clinical Pharmacology & Therapeutics 86, 585 (December 2009). doi:10.1038/clpt.2009.207 Authors: R M Ward & S E Kern
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