Excessive in Medical Technology

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

... of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder ... wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights. ... The NUVIGIL sNDA for the treatment of excessive sleepiness associated with jet lag disorder is ...

FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

... complications may result from excessive increases in platelet counts. excessive doses of PROMACTA or medication errors that result in excessive doses of PROMACTA may increase platelet counts to ...

As Summer Heats Up, New Survey Reveals Need for Effective Sweat Treatments

... a treatable condition called hyperhidrosis(1), or excessive sweating, the humidity can be ... to suffer from hyperhidrosis -- even less from excessive underarm sweating specifically. The findings ... Pieretti, says, "Many people do not realize that excessive underarm sweat is a treatable medical condition, ...

FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment

... voted that, with appropriate labeling around excessive sedation events, Zyprexa(R) long-acting injection ... with the exception of post- injection excessive sedation events, which also include dizziness, ... To help minimize the risks associated with these excessive sedation events, Lilly included a proposed plan ...

BioMarin Initiates Phase 1/2 Clinical Trial for GALNS for Morquio A Syndrome

... by deficient activity of N-acetylgalactosamine 6-sulfatase (GALNS) causing excessive lysosomal storage of keratan sulfate (KS). This excessive storage causes a systemic skeletal dysplasia, short stature, and joint ...

Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet Lag Disorder

... trial of NUVIGIL(R) (armodafinil) Tablets [C-IV] as a treatment for excessive sleepiness associated with jet lag disorder. Based on these findings, ... The efficacy and safety of NUVIGIL as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course ...

February 2009 Mayo Clinic Women's HealthSource Highlights Diabetes and Heart Disease, Going Vegetarian and Tinnitus

... and cancer drugs can cause or worsen tinnitus. Aspirin --- taken in excessive amounts --- can cause temporary ringing in the ears, too. The ... external sounds than be distracted by an internal noise. Avoiding excessive noise. Ear plugs can be helpful when operating noisy machines. ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... complications may result from excessive increases in platelet counts. excessive doses of Nplate or medication errors that result in excessive Nplate doses may increase platelet counts to a level that produces ...

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

... often have a difficult time managing their disease. They may experience excessive bruising, bleeding and sometimes more serious hemorrhages that can rarely ... Complications: Thrombotic/thromboembolic complications may result from excessive increases in platelet counts. Excessive doses of PROMACTA or medication ...

Gaining Too Much Weight During Pregnancy Nearly Doubles Risk of Having a Heavy Baby

... & Gynecology, the study found that more than one in five women gains excessive weight during pregnancy, doubling her chances of having a baby that weighs ... the birth weight, this is the first study to determine that women who gain excessive weight are even more likely to have heavy babies than women who are ...

Addrenex Pharmaceuticals Announces Positive Phase III Clinical Results for Clonicel to Treat ADHD

... may occur when the body's adrenergic system is in overdrive, producing excessive levels of the stress hormone adrenaline. Such symptoms include emotional ... anxiety, stress and fear, he said. Scientists have implicated an excessive stress response to a wide array of disorders, from ADHD and Tourette's ...

Impliant Restarts Pivotal Clinical Trial for Patented TOPS(TM) Spine System

... Development team, it was determined that device misalignment coupled with excessive shear loading caused the failure. As a result, Impliant has made a few ... way they responded to the one device failure encountered in the study. excessive shear force has contributed to the failure of several posterior motion ...

Five Clinical Studies to Receive $2.5 Million Under Foundation's 2007 Clinical Discovery Program

... are a side effect of long-term levodopa treatment), sleep disorders and excessive salivation. "The Michael J. Fox Foundation is committed to driving ... -- Elkan Gamzu, Ph.D., of NeuroHealing Pharmaceuticals, Inc. will focus on excessive salivation that leads to drooling, a major quality of life issue for ...

Vanda Pharmaceuticals Reports Third Quarter 2007 Results

... top-line results from a Phase II clinical trial evaluating VSF-173 in excessive sleepiness. FINANCIAL DETAILS -- Operating Expenses. Third quarter 2007 ... third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness, which recently completed its Phase II study. For more on Vanda ...

Promising Cystic Fibrosis Compound on Track for Development

... cause irreversible lung damage. A common condition in CF patients is the excessive absorption of sodium by affected cells, such as those lining the lungs, ... Parion 680 try to remediate this condition by decreasing the CF cell's excessive absorption of sodium. Gilead's commitment ensures that Parion 680 will be ...

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

... and developed at Lexicon to reduce serotonin production by inhibiting tryptophan hydroxylase (TPH), a key enzyme in the synthesis of serotonin. excessive levels of serotonin have been implicated in symptoms associated with carcinoid syndrome. Serotonin's breakdown product, 5-HIAA, is a biomarker used ...

Neuroscience Researcher Has Positive Message for International Alzheimer's Awareness Week, July 6 - 12: 'Even Though World Economy is Declining, Alzheimer's Research is Advancing'

... biotech company, Quincy Bioscience ( www.quincybioscience.com ), says several recent studies have confirmed a suspected link between unregulated, excessive calcium levels within the neurons and the occurrence of Alzheimer's disease. "Simply put, we now know that it is 'calcium overload' within the ...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

... Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine ...

Acute Lymphoblastic Leukemia, the Most Common Childhood Cancer, Is Curable Without Preventive Cranial Radiation

... Sciences and senior author of the paper. "Personalized therapy that we use avoids over- or under-treatment to maximize the cure rate while preventing excessive toxicity." The researchers reported that this therapy produced a projected cure rate of 90 percent for all the patients, which is the best ...

Neurocrine Biosciences Presents Elagolix Data

... translated in a dose related fashion to maintenance of low estradiol levels over the six week period without inducing severe hot flashes or excessive bone resorption as determined by n-telopeptide. Consistent pharmacokinetic profiles were maintained throughout the 42 days of treatment, and adverse ...

Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

... through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA for the treatment of excessive daytime sleepiness (EDS) and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine ...

CEL SCI Collaborators Demonstrate Novel L.E.A.P.S. Vaccines Immunize Mice Against Tuberculosis Antigens and Suggest Potential to Treat Swine and Other Influenzas

... It is for this reason that CEL-SCI believes that the L.E.A.P.S. technology, which induces an effective protective immune response without causing excessive amounts of pro-inflammatory cytokines, may be effective against H1N1 influenza. In prior tests involving L.E.A.P.S. herpes simplex vaccines, ...

vProtect(TM) Luminal Shield Stabilizes Vulnerable Plaque

... Prescient CEO Patricia Scheller, "In the future, we hope that the Shield will be used to stabilize these soft, rupture-prone lesions without causing excessive injury to the vessel wall like traditional balloon-expandable stents. We are very encouraged by the healthy endothelial tissue coverage and reduced ...

Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting

... death following induction chemotherapy in older adults with AML. Important Safety Considerations Leukine is contraindicated in patients with excessive leukemic blasts in bone marrow or peripheral blood (10 percent), in patients with known hypersensitivity to GM-CSF, yeast derived products or any ...

In Rare Disorder, a Familiar Protein Disrupts Gene Function

... CdLS affects multiple organs and typically results in distinctive facial features, such as thin eyebrows that join, long eyelashes, thin lips, and excessive body hair. It affects an estimated one in 10,000 children. In the past, CdLS was only recognized in its very severe form that was often fatal in ...

Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults

... and three million people in the U.S.--making it more common than multiple sclerosis and Parkinson's disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by ...

Scientific Data Relating to Cinryze(TM) Presented at 6th Annual C1 Inhibitor Deficiency Workshop

... for prophylaxis of HAE in the U.S.; The abstract suggested that patients with frequent HAE attacks, severe attacks, past laryngeal attacks, excessive loss of work or school, significant anxiety and poor quality of life could be considered for prophylaxis therapy, especially for those that fail, are ...

Type 2 Diabetes: An Epidemic Among America's Youth

... said A. Jay Cohen, MD, FACE, session moderator and pediatric endocrinologist. "The rapid rise in obesity, physical inactivity and the consumption of excessive calories seems to have led to the epidemic of children with type 2 diabetes." The National Institutes of Health (NIH) is conducting two ...

Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

... United States for the treatment of acute pain. Opioids may be associated with a variety of unwanted side effects, including respiratory depression, excessive sedation, nausea, vomiting, constipation, cognitive impairment, and others. The only non-opioid intravenous analgesic currently available in the ...

Addrenex Pharmaceuticals Expands Product Pipeline by Licensing New Drug to Treat Narcolepsy

... several potential benefits over currently marketed drugs for narcolepsy, according to Khayrallah. ADX-N05 has shown the potential to treat excessive daytime sleepiness as well the associated symptom of cataplexy, an abrupt and temporary episode of weakness that can result in collapse. ADX-N05 also ...

Potentia Pharmaceuticals' POT-4 Drug Candidate for Age-Related Macular Degeneration Successfully Completes Phase I Clinical Trial - Prepares for Phase II

... part of the body's defensive immune response against pathogens such as bacteria and viruses. In spite of its defensive function, inappropriate or excessive complement activation can have destructive consequences. Over the past three years, multiple scientific publications have strongly linked variants of ...

Tufts Medical Center Researchers Create a New Predictive Model for Age-related Macular Degeneration (AMD)

... concerned about AMD, or any patient with early stages or a family history of AMD, even more incentive to avoid risk factors such as smoking and excessive weight." The study included 1,446 individuals from the Age-Related Eye Disease Study who had 6.3 years of follow-up, of which 279 progressed to ...

Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failure Patients

... was observed in the first 11 patients. The investigators recognized that the risk of bleeding complication rose with age, with a likely cause being excessive anticoagulation/anti-platelet regimen. The investigators agreed to follow a less intensive aniticoagulation/anti-platelet regimen, which resulted in ...

Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression

... launch NUVIGIL, the longer-lasting isomer of modafinil, in the third quarter of 2009. NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. ...

CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

... one person per million, with an estimated prevalence in the U.S. of approximately 300 patients. Symptoms of congenital fibrinogen deficiency include excessive bleeding following injury, bruising, bleeding of the umbilical cord at birth and from the site of the umbilical stump in a newborn, spontaneous ...

March 2009 Mayo Clinic Health Letter Highlights Knee Repair Surgery, Anxiety Disorder and Preventing Blood Clots

... falling or staying asleep, difficulty concentrating, fatigue, muscle tension, restlessness, feeling out of breath, nausea, diarrhea, headaches and excessive irritability. Signs and symptoms appear gradually over time. Some who have GAD cannot recall the last time they felt at ease. Often the ...

Galderma Announces Interim Data Relating to Sequential Treatment Regimen of Clobex(R) Spray Followed by Vectical(TM) Ointment in Managing Plaque Psoriasis

... in parameters of calcium metabolism occur, Vectical(TM) Ointment should be discontinued until these normalize. Patients should be cautioned to avoid excessive exposure to natural or artificial sunlight after applying the ointment. If severe irritation occurs discontinue use. Avoid contact with eyes, lips ...

Dermatologists Caution That Severe Cases of Psoriasis Can Be Associated With Other Serious Medical Conditions

... condition and its relationship to other serious medical conditions. Dr. Gelfand explained that for the last two decades, research has shown that excessive inflammation is a critical feature of psoriasis. This discovery has led to innovative approaches to treating psoriasis, with therapies targeting ...

Study Demonstrates Restylane(R) Effect Lasted 18 Months in 97% of Patients With One Repeat Injection

... redness, pain, bruising, and tenderness at the injection site, which typically resolve in less than seven days. Avoid exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather until any initial swelling and redness have resolved. Safety has not been established for use ...

Cymbalta(R) Significantly Reduced Osteoarthritis Knee Pain in New Study

... in the study (occurred at a rate of greater than or equal to 5 percent and at least twice the rate of placebo) included nausea, constipation and excessive sweating (hyperhidrosis). Adverse events were similar to those seen in previous duloxetine studies. Additional Study Highlights -- ...