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New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)

... of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth. The most common ... XR were: children - decreased appetite, difficulty falling asleep, stomachache, and emotional ...

Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia

... a Phase II trial in Insomnia characterized by difficulty in maintaining sleep, also known as sleep ... a week, symptoms of SMI that are characterized by difficulty staying asleep and unrefreshing sleep. In many ... related to SMI rather than sleep initiation or difficulty in falling asleep. In addition, this type of ...

Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings

... the night when patients awaken and have difficulty returning to sleep PT. RICHMOND, Calif., Oct. 1 ... they awakened in the middle of the night and had difficulty returning to sleep. This Phase 3 clinical trial ... a middle of the night awakening is followed by difficulty returning to sleep. Phase 3 clinical trials have ...

Phase III Data Show Vanda Pharmaceuticals' Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

... the study focused upon recruiting subjects with difficulty falling asleep and that there was no WASO entry ... in many patients, especially those who have difficulty falling asleep," said Charles A. Czeisler, PhD, ... American adults.(3,4) It is characterized by difficulty falling asleep, waking frequently during the ...

Arena Pharmaceuticals Presented Positive Phase 2a Clinical Trial Results of APD125 for the Treatment of Insomnia at 22nd Annual Meeting of the Associated Professional Sleep Societies

... to nonrefreshing sleep, frequent wakening with difficulty falling back to sleep, difficulty falling asleep or waking too early. Most ... is often associated with fatigue, mood changes, difficulty concentrating and impaired daytime functioning. ...

Intermezzo(R) 3.5 mg Achieves Greater Early Bioavailability Than Ambien(R) 10 mg Despite 65% Lower Dose

... by middle-of-the-night (MOTN) awakenings with difficulty returning to sleep. "One significant challenge ... were verified to suffer from MOTN awakenings with difficulty returning to sleep. These patients experienced a ... who awaken in the middle of the night and have difficulty returning to sleep. Phase 3 clinical trials have ...

CAPHOSOL(R) Relieves Oral Mucositis (OM) and Improves Quality-of-Life in Cancer Patients Receiving Chemoradiation

... severe pain, are more prone to infection and have difficulty eating and swallowing. Our research concludes ... (dryness of the mouth or throat), difficulty eating and drinking, as well as difficulty with speech; these effects can significantly ...

Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)

... for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. "This is the fifth product ... up frequently during the night (32%), having difficulty falling asleep (21%), and waking up too early and ...

Arena Pharmaceuticals Initiates Phase 2b Clinical Trial of APD125 for the Treatment of Insomnia

... to nonrefreshing sleep, frequent wakening with difficulty falling back to sleep, difficulty falling asleep or waking too early. Most ... is often associated with fatigue, mood changes, difficulty concentrating and impaired daytime functioning. ...

Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status

... for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. This is the first clinical ... up frequently during the night (32%), having difficulty falling asleep (21%), and waking up too early and ...

Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia

... is being evaluated in insomnia patients who have difficulty maintaining sleep after initial sleep onset. When ... to nonrefreshing sleep, frequent wakening with difficulty falling back to sleep, difficulty falling asleep or waking too early. Most ...

Dry Mouth Linked to Prescription and Over the Counter Drugs

... the most common symptoms reported by patients include constant thirst and difficulty eating, swallowing, or speaking. Foamy or stringy saliva, irritation of ... most common symptom communicated by patients; 44 percent say patients have difficulty eating, swallowing or speaking; More than 92 percent report that ...

Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)

... reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth. Aggression, new abnormal ...

Meritage Pharma Initiates Phase 2b Clinical Trial of Oral Viscous Budesonide for Pediatric Patients With Eosinophilic Esophagitis

... (EoE), an allergic inflammatory condition of the esophagus. EoE can cause difficulty in swallowing and heartburn, and in severe cases it can lead to food ... pump inhibitor therapy, failure to thrive, poor appetite, malnutrition and difficulty sleeping. The double-blind, randomized, placebo-controlled 12-week ...

Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD

... reported in studies of Vyvanse were: children -- decreased appetite, difficulty falling asleep, stomachache, and irritability; adult -- decreased appetite, difficulty falling asleep, and dry mouth. Aggression, new abnormal ...

Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD

... reported in studies of Vyvanse were: children -- decreased appetite, difficulty falling asleep, stomachache, and irritability; adult -- decreased appetite, difficulty falling asleep, and dry mouth. Aggression, new abnormal ...

Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder

... difficulties frequently associated with the disorder, which are primarily difficulty falling asleep and staying asleep," says Maurizio Fava, MD, Professor of ... and sleep-related next-day functioning. About Insomnia Insomnia -- difficulty falling asleep, staying asleep or waking too early and not being able to ...

Results of the Phase III Pivotal Study of VYVANSE(TM) (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults Presented at National Scientific Meeting of Psychiatrists

... reported in studies of Vyvanse were: children -- decreased appetite, difficulty falling asleep, stomachache, and irritability; adult -- decreased appetite, difficulty falling asleep, and dry mouth. Aggression, new abnormal ...

Study Demonstrates Lexapro(R) Significantly Improves Depression Symptoms in Adolescents

... of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low self-esteem. ... statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... sad or irritable mood; pronounced changes in sleep, appetite, and energy; difficulty thinking, concentrating, and remembering; physical slowing or agitation; ... the anxiety include fatigue, headaches, muscle tension, muscle aches, difficulty swallowing, trembling, twitching, irritability, sweating, nausea, ...

Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status

... is being developed for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. Alexza filed an Investigational New Drug application ...

Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression

... of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low ... statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new ...

Replidyne's Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile

... or any other indication. "CDAD is a challenging disease because of the difficulty in managing patients with severe manifestations as well as the problem of ... that disrupt normal intestinal flora, an ageing population, and difficulty of eradicating C. difficile spores. However, more recently, CDAD has been ...

Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)

... extended release has been determined; (2) contact a physician if any difficulty in breathing occurs; (3) inform the physician or dentist before any ... of and accrued interest on the notes or, in the alternative, damages, the difficulty of predicting FDA filings and approvals, acceptance and demand for new ...

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

... nerve impulses traveling to and from the brain and spinal cord(iii). Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis(iii, iv). MS is thought to affect as many as 2.5 million people worldwide, including approximately 400,000 in the ...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

... of the airways that transport air from the nose and mouth to the lungs.(2) Asthma symptoms can be triggered by allergens or irritants and can include difficulty breathing, wheezing, coughing, shortness of breath and tightness in the chest.(2) With more than 22 million people living with asthma in the United ...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

... side effects of TEKTURNA and TEKTURNA HCT include an allergic reaction involving swelling of the face, lips, throat and/or tongue that may cause difficulty in breathing and swallowing (stop taking TEKTURNA or TEKTURNA HCT and contact your doctor immediately), and low blood pressure, especially if you ...

Prospective Clinical Advantages of Trabecular Metal(TM) Technology Highlighted in Comparative Study

... It is well established that a decrease in bone density may compromise the long term success of the primary surgery and may increase the difficulty and expense of revision reconstruction. Acetabular stress-shielding can also exacerbate patients' osteolytic response to bearing surface particles, ...

June 2009 Mayo Clinic Women's HealthSource Highlights Summer Skin Problems, Low Vision and Pilates

... available when prescription eyeglasses, contact lenses, medicine or surgery don't improve vision sufficiently. Low vision is not the normal difficulty reading the small print that can accompany aging. Low vision is caused by eye diseases such as macular degeneration, glaucoma, cataracts, diabetic ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... grip and daily activities). The ability to perform each category is measured on a scale 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty or with assistance, and 3 = unable). (4) ACR20, ACR50, ACR70 represent the percentage of reduction (20%, 50%, 70%) in certain RA symptoms and ...

Tolerx Presents Data at 69th Scientific Sessions of the American Diabetes Association

... . About Type 1 Diabetes Diabetes (medically known as diabetes mellitus) is the name given to disorders in which the body has difficulty regulating its blood glucose (sugar) level. There are two major types of diabetes: type 1 and type 2. Type 1, previously known as juvenile diabetes ...

SCAI Statement on the BARI 2D Trial (Bypass Angioplasty Revascularization Investigation With Diabetes Trial) Presented at the American Diabetes Association (ADA) Annual Scientific Sessions and Published in The New England Journal of Medicine

... of the Cardiac Catheterization Laboratory, South Texas VA Medical Center. "The patients I see with diabetes and heart disease frequently have difficulty complying with a drug regimen that includes upwards of ten pills per day, often coupled with insulin injection. Not surprisingly, noncompliance can ...

Large, Long-Term Study Shows Avandia Has No Increased Overall Cardiovascular Risk Compared to Other Commonly Used Diabetes Medicines

... medicines you are taking. If you take AVANDIA, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant. Before taking AVANDIA, review your medical history and tell ...

New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

... system disorders - numbness, weakness, tingling, changes in your vision or seizures. Allergic reactions during or after the infusion - hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Lupus-like syndrome - chest discomfort or ...

Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation

... the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely ...

Spirus Medical Announces Complete Examinations of the Small Intestine by Physicians Using Endo-Ease(TM)

... Disease Week 2009 in Chicago, May 30 through June 4. Complete examination of the small intestine has been elusive in regular practice due to the difficulty in maneuvering an endoscope through the long, tortuous path in the body. The small intestine is about 20 to 23 feet long and other methods for ...

Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients

... grip and daily activities). The ability to perform each category is measured on a scale 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty or with assistance, and 3 = unable). (2) The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with ...

Study Confirms Effectiveness of Innovative Prism Glasses For Hemianopia Patients

... the glasses at the end of the study. They also found that all patients had expansion of their visual field of about 22 degrees and expressed reduced difficulty in noticing and avoiding obstacles. On the other hand, only two patients demonstrated even an intermittent adaptation to the change in visual ...

Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results

... infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Impaired Renal Function In studies of ACE inhibitors in patients with unilateral or bilateral renal ...

New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure

... infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Impaired Renal Function In studies of ACE inhibitors in patients with unilateral or bilateral renal ...
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