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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...

JACC Publishes Long-Term Safety and Tolerability Data from Ranolazine Open Label Experience (ROLE) Program

PALO ALTO, Calif., March 14, 2007 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today that the Journal of the of Cardiology (JACC) has published data from the Ranolazine Open Label Experience (ROLE) program, which showed long-term therapy with Ranexa(R) (ranolazine extended-release tab...

Vical's Vaxfectin Adjuvant With Needle-free Delivery Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation Without Tolerability Issues

MALAGA, Spain, May 23, 2007 /PRNewswire-FirstCall/ -- Vical Incorporated today announced that in a recently completed animal study, a DNA vaccine formulated with the company's patented Vaxfectin(TM) adjuvant and delivered by needle-free injection yielded significantly higher antibody responses tha...

12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA (methylphenidate transdermal system)

SAN DIEGO, May 23, 2007 /PRNewswire-FirstCall/ -- Shire plc announced that DAYTRANA(TM) (methylphenidate transdermal system), the first and only non-oral medication approved for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years, provided significant improv...

Bionovo's MF101 Shows Positive Safety, Tolerability and Efficacy in Phase 2 Trial

EMERYVILLE, Calif., June 04, 2007 /PRNewswire-FirstCall/ -- Bionovo, Inc.'s lead drug candidate, MF101, showed positive Phase 2 results for the treatment of hot flashes associated with menopause. Two hundred and seventeen women were enrolled in the company's double-blind, placebo- controlled, rand...

OREXIGEN Therapeutics Announces Sustained-Release Formulation of Zonisamide Shows Improved Tolerability When Compared to Immediate Release Formulation

Orexigen(TM) is evaluating zonisamide SR as a novel component in EMPATIC(TM) Phase IIb obesity trial SAN DIEGO, June 07, 2007 /PRNewswire-FirstCall/ -- Orexigen(TM) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of central nervous system disorders with an initial focus o...

Geron's Telomerase Inhibitor Cancer Drug Demonstrates Good Pharmacokinetics and Tolerability in Phase I/II Trial

MENLO PARK, Calif.--(BUSINESS WIRE)--Jun 12, 2007 - Geron Corporation's (Nasdaq:GERN) telomerase inhibitor cancer drug, GRN163L, has demonstrated good pharmacokinetics and tolerability in its ongoing Phase I/II trial involving patients with chronic lymphocytic leukemia (CLL), according to data pres...

First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes

-- Additional Findings Reported on Glucose Homeostasis Effects in Normal and Diabetic Rats -- CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- In a 14-day, Phase IIa study of the safety profile of multiple doses of the investigational compound dapagliflozin, a selective inhibitor of the Sodium-Glu...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

...if denosumab is superior to Zometa with respect to the first on-study SRE, as well as first-and-subsequent on-study SREs, and to assess the safety and tolerability of denosumab compared with Zometa. About Denosumab and Amgen's Research in Bone Biology Denosumab is the first fully human monoclonal anti...

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

... globally in 2008. Access believes that ProLindac, as a well-tolerated and active DACH platinum, represents a important improvement in the design and tolerability of platinum chemotherapies. Later this month, an Access management and clinical development team is meeting with Access' partner, Aosaikang M...

FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

...ee in four patients discontinue therapy within 18 months due to either poor tolerability or incomplete efficacy. Metabolic safety, including weight gain, elevation...o lack of efficacy or side effects, including metabolic side effects. Poor tolerability frequently leads to treatment discontinuation even when the treatment is pr...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

... on the secondary endpoints of the study. The data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues. The most common side effect reported was injection site reaction. More details of the MAESTRO-01 study results are expected to be presented at...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... determine whether an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development pro...f clinical trial data by the FDA in support of regulatory approval; and the tolerability profile and/or benefits of its product candidates. Such statements are bas...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

... global development strategy." Lexicon recently initiated a Phase 2 clinical trial of LX1032 in the United States to evaluate the safety and tolerability of LX1032 and its effects on symptoms associated with carcinoid syndrome. The study is designed as a four-week, randomized, double-blind, placebo-con...

UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

...udy are to evaluate: overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), and to further evaluate the safety and tolerability of BSI-201 in combination with gemcitabine and carboplatin. Phase II of the study in triple negative breast cancer patients found that BSI-20...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

...standard doses of common blood pressure medications such as ACE inhibitors or diuretics. "R788 continues to perform with strong efficacy and good tolerability in the groups of patients with RA who have failed to respond to methotrexate," said Elliott Grossbard, M.D., chief medical officer for Rigel. "We now...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

...f denosumab was superior to Zometa with respect to the first on-study SRE, as well as first-and-subsequent on-study SREs, and to assess the safety and tolerability of denosumab compared with Zometa. About Denosumab and Amgen's Research in Bone Biology Denosumab is the first fully human monoclonal antib...

Alcon Commences Phase 2 Clinical Trial of NovaBay's NVC-422 for Viral Conjunctivitis

...ivitis study follows a recently completed Phase 1 trial in which safety and tolerability were successfully demonstrated in 120 healthy volunteers with no reported s...ve a broad therapeutic index while providing a high degree of potency, good tolerability as well as dosing versatility and flexibility. About Alcon Alcon,...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

... sufentanil demonstrates a therapeutically appropriate pharmacokinetic profile for post-operative PCA usage and has the potential for improved patient tolerability over IV PCA morphine. About AcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals is a privately held pharmaceutical company dedicated to the d...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

...nt decrease in seizure frequency was sustained over the one-year open label treatment period and was consistent regardless of baseline therapy. tolerability The safety profile of ESL was favourable. The majority of treatment related adverse events were mild or moderate in intensity. After 6 weeks of...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

...domised, double-blind, placebo-controlled, parallel-group design, including an open-label tiotropium bromide arm, and will assess efficacy, safety and tolerability of NVA237 in patients with COPD. It will include approximately 1000 patients with moderate to severe COPD from study centres across the USA, Europe an...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

...the Dose Response for Flushing , Safety and tolerability of Escalating Doses of Niacin in Fasted and Fed He...ood on niacin-induced flushing, and the safety and tolerability of varying doses of niacin. Volunteers were broken... Phase II Multiple-Dose Study of the Safety and tolerability of Niacin 30 mg and 60 mg Combined With Oxycodone ...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

...e management of dyslipidemia in elderly patients, with a similar safety and tolerability profile to low-dose pravastatin. The Phase III data were presented today b...ults of this study show that pitavastatin has a robust efficacy, safety and tolerability profile at the proposed starting dose and offers a low-dose alternative for...

Isis Highlights New Data on Antisense Drugs to Treat Type 2 Diabetes and Obesity at ADA Scientific Sessions

...g the past year on ISIS-SGLT2Rx extends previous findings and demonstrates potent and sustained reduction of blood glucose levels with good safety and tolerability in multiple animal models including non-human primates. Collectively, the data suggest that ISIS-SGLT2Rx could result in sustained and significant re...

The Lancet Publishes Direct Comparison Study Between Liraglutide and Exenatide

... the principal investigators in the study. "The clinical benefits that liraglutide provides -- from greater glucose lowering to weight loss to better tolerability and improvements in beta-cell function -- represent a clinically meaningful treatment advance for patients with type 2 diabetes." LEAD(TM) 6 was ...

FYI From Human Genome Sciences: GlaxoSmithKline Study Shows GSK's Novel Diabetes Treatment Syncria(R) (Albiglutide) Improves Glucose Control, Reduces Weight

...f Syncria is commercialized. In February 2009, GSK announced initiation of a Phase 3 clinical trial program to evaluate the efficacy, safety and tolerability of Syncria in the long-term treatment of type 2 diabetes mellitus. All inquiries regarding the Phase 2 data presented at ADA, or about the developmen...

Micromet's Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients

...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...

Micromet Presents Update on Blinatumomab's Response Rate and Duration in a Phase 1 Study in Non-Hodgkin's Lymphoma Patients

...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...

Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting

...one other botulinum toxin in the treatment of cervical dystonia," said Pappert. First Study - Title Overall clinical efficacy and overall tolerability of NT-201 (Xeomin(R); botulinum neurotoxin free from complexing proteins) authored by R. Benecke, S. Grafe, I. Sassin, and G. Comes. Method E...

Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162

... -2.1 1.1 Minor hypoglycemic events/patient/year 0.23 0.21 1.76 Safety and tolerability of liraglutide The rate of minor hypoglycemia was statistically significantly lower with both liraglutide dose groups compared to the glimepiride-...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

...nd completing our NDA submission by the end of the year." Safety and tolerability Profile Lorcaserin was very well tolerated. Discontinuation rates for...3.0% vs. 3.0%, respectively). In addition to the previously announced tolerability data, today's presentation also reported that lorcaserin demonstrated no in...
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