Tolerability

Study Shows Organon's Asenapine Demonstrates Efficacy and Tolerability in Treating Acute Schizophrenia

OSS, Netherlands, Nov. 14 /PRNewswire/ -- Asenapine -- a fast- dissolving, sublingual tablet being developed by Organon -- was shown to be effective and well-tolerated in patients with acute schizophrenia, according to a six-week study published in the current issue of the Journal of Clinical ...

Phase II Data Show Efficacy and Tolerability of Tapentadol in Chronic Pain Treatment

The German pharmaceutical company Grunenthal GmbH presented the first clinical evidence for the efficacy and tolerability of tapentadol ER (extended release) for patients suffering from chronic pain at the Annual Congress of the European League Against Rheumatism (EULAR), 13-16 June 2007, Barcelon...

ViroPharma Announces Initiation Of Non-Toxigenic Clostridium Difficile Phase 1 Program

... non-toxin producing C. difficile thereby protecting patients until normal GI flora returns." The Phase 1 study will determine the safety and tolerability of NTCD dosed orally as single and repeat escalating doses in healthy young (18-45 years of age) and older (60 years of age and older) adults. The stu...

Micromet, Inc. Reports Second Quarter 2009 Financial Results

...f the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will no...

Nephrologists Indicate High Interest in AMAG Pharmaceuticals' Newly Approved Feraheme According to Latest BioTrends Report

...rphosphatemia, and impact on calcification. Although these are areas where Amgen's Sensipar has a competitive advantage, Sensipar's reimbursement and tolerability profile, as well as the fact that Nephrologists continue to reserve it for patients with extremely elevated PTH, seems to hold it back from being used...

Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for Metastatic Breast Cancer

...vanced breast cancer. In the trial, Bezielle showed an excellent safety and tolerability profile, and also showed promising indications of efficacy in a difficult-t...hase 1A study, Bezielle demonstrated very limited toxicity with a favorable tolerability profile and encouraging clinical activity among a cohort of patients with m...

Lexicon Initiates Phase 2 Clinical Trial of LX2931 in Patients With Rheumatoid Arthritis

...splantation. The Phase 2 clinical trial is designed as a 12-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX2931 and its effects on symptoms associated with rheumatoid arthritis. The study will include multiple centers in the United States and Eastern ...

FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia

... physicians and patients." "LIVALO has a robust safety, efficacy and tolerability profile and offers an attractive alternative for patients with primary hype...diabetes and patients at higher cardiovascular risk. The overall safety and tolerability of LIVALO are consistent with other commonly prescribed statins. LIV...

Arena Pharmaceuticals Announces Second Quarter 2009 Financial Results and Recent Developments

... plan to submit by the end of this year," stated Jack Lief, Arena's President and Chief Executive Officer. "Based on its emerging efficacy, safety and tolerability profile, lorcaserin has the potential to be an important new treatment option for patients needing to better manage their weight and improve their ove...

Zogenix and Astellas Enter Exclusive Co-Promotion Agreement in the US for Newly Approved Sumavel(TM) DosePro(TM)

... tingling, warm/hot sensations), dizziness and flushing. Most side effects lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel DosePro to sumatriptan injection, most injection site reactions resolved spontaneously. About DosePro technology The DosePro te...

Tolerability in Medical Technology

Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures

SEATTLE, Dec. 6 /PRNewswire/ -- Phase III data on carisbamate, an investigational compound recently filed with the FDA for the adjunctive treatment of partial onset seizures (POS) in patients 16 years of age and older, was presented today during the poster sessions of the 32nd Annual Meeting of th...

Analysis of Long-Term Vicriviroc Data Provides Evidence of Sustained Viral Suppression, Increased CD4 Cell Counts and Tolerability in Treatment-Experienced HIV-Infected Patients

Data Analysis of Up to Four Years of Treatment Presented at ICAAC/IDSA 2008 Annual Meeting WASHINGTON, Oct. 26 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported a data analysis showing that vicriviroc, its investigational CCR5 receptor antagonist, demonstrate...

NVA237 Phase II Results Presented at the European Respiratory Society Annual Meeting Show Promising Efficacy and Tolerability With Potentially Faster Onset Than Tiotropium

TOKYO and CHIPPENHAM, England, October 7 /PRNewswire-FirstCall/ -- Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE: VEC), announce results of two Phase II studies evaluating the efficacy, safety and tolerability of NVA237 presented at the annual...

Anti-TGF-Beta Antisense AP 12009 Shows Very Good Safety and Tolerability in Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma

CHICAGO and REGENSBURG, Germany, June 2 /PRNewswire/ -- The TGF-beta 2 inhibitor AP 12009, developed by Antisense Pharma, reveals very good safety and tolerability in the systemic treatment of pancreatic carcinoma, malignant melanoma and colorectal carcinoma. AP 12009, administered intravenous...

Results of Phase 3 Study Show Tapentadol IR Relieves Acute Pain and Offers Favorable Gastrointestinal Tolerability Profile

TAMPA, Fla., May 9 /PRNewswire-USNewswire/ -- Osteoarthritis is a painful and potentially debilitating condition that affects almost 50 million people in the United States. It is caused by deterioration of cartilage in bone joints. The novel investigational pain medication tapentadol, a central...

New Study Suggests Tapentadol IR for Acute Pain Is Associated With Improved Gastrointestinal Tolerability Compared to Oxycodone IR

TAMPA, Fla., May 9 /PRNewswire-USNewswire/ -- Many strong acting pain medications have bothersome side effects. These can include nausea and vomiting with short-term use, and constipation with longer, chronic use. Such symptoms can lead patients to discontinue treatment, adding additional comp...

Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients

LONDON, Jan. 16 /PRNewswire/ -- Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on the development of novel anti- inflammatory drugs, today announced the preliminary safety results from its Phase I safety and tolerability study of MRX-4 in 16 patients suffering from allergic...

IDM Pharma Announces Updated Phase 2 UVIDEM(R) Results Showing Durable Disease Control and Tolerability in Advanced Melanoma Patients

IRVINE, Calif., Nov. 2 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI ) today announced updated results from a Phase 2 UVIDEM(R) (IDD-3) melanoma vaccine clinical trial (DC-MEL-202). The updated results showed that the investigational agent UVIDEM showed evidence of clinical activit...

Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome

- Data Presented at the 132nd Annual Meeting of the American Neurological Association in Washington, D.C. - ATLANTA, Oct. 8 /PRNewswire/ -- UCB, Inc. presented results from two Phase III pivotal trials and one open-label extension trial of rotigotine transdermal system for the...

New, Published GELNIQUE Data Show Efficacy, Convenience and Excellent Tolerability

CORONA, Calif., March 16 /PRNewswire-FirstCall/ -- New Phase 3 data, published in the April issue of The Journal of Urology, show that GELNIQUE(TM) (oxybutynin chloride) Gel 10%, the first and only topical gel approved for the treatment of overactive bladder (OAB), is effective at improving th...

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Tolerability in Medical Products

Optimark®

Description:...onvenient packaging options for just the right amount of contrast, packaged for efficient, problem-free delivery. You can trust OptiMARK® for the tolerability and diagnostic accuracy you expect from a gadolinium extracellular contrast agent. Extensive clinical trials have demonstrated safety, including in pa...
Company:Mallinckrodt, Inc.

Optimark

Description:...has convenient packaging options for just the right amount of contrast, packaged for efficient, problem-free delivery. You can trust OptiMARK for the tolerability and diagnostic accuracy you expect from a gadolinium extracellular contrast agent. Extensive clinical trials have demonstrated safety, including in pa...
Company:Mallinckrodt, Inc.

Sterillium Rub

Features:...ow rate of scaling and has skin-smoothing properties, even with intensive long-term use Sterillium Rub contains special emollients for improved skin tolerability and protection ...
Company:Medline Industries, Inc.

Tolerability in Biological News

Biolex presents Locteron US Phase 2a hepatitis C data at EASL

...led prior treatment. The PLUS trial was designed to evaluate the safety and tolerability of Locteron, and to directly compare Locteron with pegylated interferon. Pa...feron that can improve patient compliance through a combination of improved tolerability and convenience." Locteron is an investigational therapeutic candidate...

Fluorescent cancer cells to guide brain surgeons

...makes the effort of intraoperative MRTs unnecessary. Further advantages of the new method are that it is tolerable, inexpensive and easy to apply. tolerability and effectiveness of the staining method will be validated next year in a larger study involving several hospitals. The scientists will monitor in a l...

Review of probiotic trial research finds only Bifantis able to claim efficacy for IBS symptoms

... found in a daily probiotic supplement by Procter & Gamble. The researchers reviewed 16 random-controlled-studies, evaluating the efficacy, safety and tolerability of probiotics in the treatment of IBS. With the exception of the Bifidobacterium infantis 35624 studies, researchers found the other trials did not ...

First trial in patients with a potential treatment of the incurable ALS muscle disease

...ion has been granted to start the first safety and tolerability trial on patients for a remedy for ALS. ALS is an ...n they'll start the first evaluation of safety and tolerability of the drug in patients by the end of this year. T...trial which is intended to evaluate the safety and tolerability of the drug and the infusion system. It is planned...

Phase III data show efficacy/safety of iclaprim in patients with complicated skin infections

...eople in the United States each year and rates of hospital- and community-acquired MRSA are on the rise. , "The high efficacy rates and favorable tolerability profile of iclaprim strongly supports its potential as a new treatment option for patients who have acquired serious infections caused by MRSA," said ...

Sirtris' review of sirtuin therapeutics for diseases of aging in Nature Reviews Drug Discovery

...ally unrelated to and one-thousand times more potent than resveratrol. Sirtris' first new chemical entity is currently being evaluated for safety and tolerability in a Phase 1a study in humans. "We are beginning to understand more about activation of other enzymes in the sirtuin family, SIRT2-7, and we're enc...

Risks and benefits of antipsychotics in children and adolescents

...5). Few well-controlled studies have assessed the efficacy, safety, and tolerability of antipsychotics in children and adolescents (Arango et al. 2004; Kumra et...ng childhood and adolescence may influence both treatment response and drug tolerability in ways not seen in adults. It is also possible that treatment may adversel...

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

...ting Phase 2 study of inhaled carbon monoxide in patients receiving renal transplants. The primary endpoint of the study is to evaluate the safety and tolerability of increasing carbon monoxide dose levels when administered as an inhaled gas to kidney transplant patients over the course of one hour in an acute ho...

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

...ting Phase 2 study of inhaled carbon monoxide in patients receiving renal transplants. The primary endpoint of the study is to evaluate the safety and tolerability of increasing carbon monoxide dose levels when administered as an inhaled gas to kidney transplant patients over the course of one hour in an acute ho...

Eribulin mesylate demonstrated anti-tumor activity in patients with advanced breast cancer

...cal trial. The study also suggests that eribulin mesylate has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling...ration. "In this study, eribulin mesylate appeared to have an acceptable tolerability profile, particularly with regard to the low incidence of peripheral neurop...

Tolerability in Biological Technology

Phase 3 Data Demonstrate Efficacy and Tolerability of Paliperidone Palmitate, an Investigational Long-Acting Therapy for the Treatment of Schizophrenia

Results of Two Trials Identify Potential Initiation Dosing Regimen TITUSVILLE, N.J., Dec. 10 /PRNewswire/ -- Paliperidone palmitate, an investigational long-acting therapy (LAT) demonstrated statistically significant symptom control compared with placebo according to the results of a 13-w...

Parion Sciences Announces Initiation of Phase I Clinical Trial to Evaluate Safety and Tolerability of GS9411

DURHAM, N.C., Dec. 4 /PRNewswire/ -- Parion Sciences, Inc. today announced that its partner, Gilead Sciences (Nasdaq: GILD ), has initiated a Phase I clinical trial of GS9411 in healthy volunteers to evaluate the safety and tolerability of the investigational compound. GS9411 is designed to inc...

Phase I Safety and Tolerability Study With EVT 302 Successfully Completed

HAMBURG, Germany and OXFORD, England, January 7 /PRNewswire-FirstCall/ -- Evotec AG (Frankfurt Stock Exchange: EVT) today announced that it has successfully completed a Phase I safety and tolerability study with EVT 302. The preliminary results confirm the good tolerability profile of EVT 302 ...

NeurogesX Reports Second Quarter 2009 Results

... determine whether an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development pro...rtnership; strategies to obtain reimbursement for end-users of Qutenza; the tolerability profile and/or benefits of NeurogesX' product candidates; expectations rega...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

.... InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. The top-line efficacy, safety and tolerability data for pirfenidone reported in this press release are from analyses of the highest areas of interest to the company based on the prior clinical expe...

Rib-X Pharmaceuticals Reports Positive Phase 2 Study Results for Radezolid in Community-Acquired Pneumonia

...tudy assessed the efficacy of three doses of radezolid, administered either once or twice a day for seven to 10 days. It also evaluated the safety and tolerability of the three doses. The study enrolled approximately 160 patients at 40 study centers across the U.S., Canada, and Russia. The primary efficacy endpoi...

Micromet Closes $80.5 Million Public Offering of Common Stock

...f the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will no...

Nile Therapeutics, Inc. Announces Dosing of First Patient in Phase 2 Study of CD-NP for the Treatment of Acute Heart Failure

...ment of acute heart failure. The single-blind, placebo-controlled Phase 2 study is designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with acute heart failure and mild to moderate renal insufficiency. Additional exploratory endpoi...

Micromet Receives European Orphan Drug Designation for Treatment of Acute Lymphoblastic Leukemia with BiTE Antibody Blinatumomab

...f the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will no...

NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results

...th respect to the NDA for Qutenza with the FDA, including the PDUFA date for the NDA; the timing and size of potential product launch of Qutenza; the tolerability profile and/or benefits of NeurogesX' product candidates and potential development partners for NeurogesX' early-stage products. Such statements are ...