King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Thera...(days. Results demonstrated a niacin dose...),Health

Date:6/25/2009

days. Results demonstrated a niacin dose-response relationship in both fed and fasted volunteers, with niacin being better tolerated in the fed state. Also, the most frequently reported adverse effects (AEs) were those commonly associated with niacin. These findings suggest that niacin will be well tolerated up to 60 mg per dose and will likely be well tolerated at 90 mg per dose.

Phase II Multiple-Dose Study of the Safety and Tolerability of Niacin 30 mg and 60 mg Combined With Oxycodone HCl 5 mg Versus Oxycodone HCl 5 mg Alone in Healthy Adult Volunteers

A Phase II study was conducted to evaluate the safety and tolerability of multiple daily doses of the active components of ACUROX(R) Tablets, and to determine if tolerance to the effects of niacin develops after repeat administration. Three groups of participants received different doses of niacin combined with oxycodone HCl, and the Side Effects and Symptoms Questionnaire (SESQ) and the Niacin Tolerability Rating Scale (TRS) were used to assess niacin tolerability end points. Results showed that approximately 75 percent of all volunteers in all groups rated the tolerability of study drugs as easy to tolerate or as having no effect, and that adverse effects (AEs) were consistent with the known safety profiles of oxycodone and niacin. These findings support the safety and tolerability of niacin in ACUROX(R) Tablets when taken at the recommended dose.

The Interaction Between Opioids and Alcohol: Results from a Global Literature Review

The potential risk for alcohol to interact with drugs and/or disrupt a drug formulation matrix is a prevalent safety concern. For extended-release opioids, there is an added concern that ethanol (EtOH) may disrupt the formulation mechanism leading to increased bioavailability of the opioid. Although the combination of EtOH and prescription opioids is frequently cited as having increased impairing effects, ver
'/>"/>

SOURCE King Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate