Breaking News
May 22, 2018 - CSIRO study urges Australians to avoid junk protein foods for healthy weight loss
May 22, 2018 - Breath Test Shows Promise for Diagnosis of Esophagogastric CA
May 22, 2018 - Common class of drugs linked to dementia even when taken 20 years before diagnosis
May 22, 2018 - Optimal Biomarker Frequency for Biosensors
May 22, 2018 - Ethics of conducting clinical research during public health emergencies
May 22, 2018 - FDA Approves Aimovig (erenumab), The First Drug Aimed at Preventing Migraines
May 22, 2018 - Warning labels on alcohol containers highly deficient, new research shows
May 22, 2018 - Doctors publish comprehensive proposal to ensure universal access to safe, affordable medications
May 22, 2018 - When is insurance not really insurance? When you need pricey dental care.
May 22, 2018 - Thyroid tumors may be more susceptible to precisely targeted radiation treatment, suggests study
May 22, 2018 - Researchers uncover clues to early lung transplant failure
May 22, 2018 - Coagulation Factor Tests: MedlinePlus Lab Test Information
May 22, 2018 - Booze ads cause risky drinking in young people
May 22, 2018 - Are you and your primary care doc ready to talk about your DNA?
May 22, 2018 - UCI research team uncovers new unexpected mode of neurotransmitter-based communication
May 22, 2018 - Researcher develops nanoparticle-based tags to detect viruses and cancer with high sensitivity
May 22, 2018 - Researchers highlight need for transgender-inclusive healthcare providers
May 22, 2018 - Celgene to share new and updated data around novel hematological therapies
May 22, 2018 - Scientists identify cell types underlying schizophrenia
May 22, 2018 - ACR urges legislative action on access and cost barriers in rheumatologic care
May 22, 2018 - Study examines link between nicotine dependence and likelihood to quit smoking after lung cancer screening
May 22, 2018 - New report highlights danger of childhood drowning in open water
May 22, 2018 - Proposed definition of patient-centeredness and engagement in healthcare
May 22, 2018 - Scientists reveal likely cause of childhood leukaemia
May 22, 2018 - Specific patterns of fat distribution linked to metabolic disease, shows study
May 22, 2018 - Novel drug prevents memory impairment in mice exposed to simulated deep space radiation
May 22, 2018 - New LIVE scoring tool effectively predicts future risk of hospitalization for COPD patients
May 22, 2018 - Most people with preclinical signs of Alzheimer’s disease may not develop dementia
May 22, 2018 - Fetal MRI can accurately identify holoprosencephaly by 18 weeks of gestation
May 22, 2018 - Multidisciplinary clinic can provide quality care for low-income patients with lung conditions
May 22, 2018 - Researchers create tool to determine patient’s response to immunotherapy drugs
May 22, 2018 - Pfizer starts Phase 1/2 study of RSV vaccine candidate in healthy adult volunteers
May 22, 2018 - New technique allows researchers to control heart cells growing in a dish
May 22, 2018 - FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia
May 22, 2018 - Making America’s doctors look more like America
May 22, 2018 - Few parents use simple strategies to protect kids from food poisoning, reports study
May 22, 2018 - Reduction in heart disease risk factors could help prevent frailty among older adults
May 22, 2018 - Study finds age-related racial disparities in youth suicide
May 22, 2018 - Childhood leukemia linked to lack of childhood infections
May 22, 2018 - Scientists identify new drug target to combat chikungunya virus
May 22, 2018 - PSCK9 inhibitors may provide benefit to atherosclerosis patients with high lipoprotein(a) levels
May 22, 2018 - Celltrion Healthcare advocates early introduction of biologics for patients to improve clinical outcomes
May 22, 2018 - Local anesthetic drug not linked to reduction in opioid use, complications after knee surgery
May 22, 2018 - FDA Alert: Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement
May 22, 2018 - Post-surgical opioids can, paradoxically, lead to chronic pain
May 22, 2018 - Flow of cerebrospinal fluid found to be key signal for neural stem cell renewal
May 22, 2018 - Nipah virus kills nine in Kerala, India
May 22, 2018 - Higher body temperatures speed the bodies’ responses to infections and tumors, finds research
May 22, 2018 - Staying up all night, sleeping all day can swiftly impact over 100 proteins in the blood
May 22, 2018 - Combination of vascular risk and brain amyloid levels may accelerate age-related cognitive decline
May 22, 2018 - ASCO: Few Eligible Smokers Had CT Screen for Lung CA in 2016
May 22, 2018 - In Brazil, patients risk everything for the ‘right to beauty’
May 22, 2018 - Women with gestational diabetes may be at greater risk for chronic kidney disease
May 22, 2018 - Flavonoid intake may reduce lung function decline that occurs with aging
May 22, 2018 - AACN brings together over thousands of nurses for annual conference
May 22, 2018 - AHA: ‘Ideal’ Heart Health Eludes More Americans
May 22, 2018 - Drug used to treat daytime sleepiness does not appear to improve driving in those with sleep apnea
May 22, 2018 - Incorporation of AI could transform cancer diagnosis in UK
May 22, 2018 - Neurological protein found to protect against inflammatory diseases
May 22, 2018 - Lipoprotein (a) Blood Test: MedlinePlus Lab Test Information
May 22, 2018 - A new molecular target identified in depression
May 22, 2018 - Researchers discover new gene locations that determine heart’s response to exercise
May 21, 2018 - HCM mutation prevents the heart from increasing pumping force, study shows
May 21, 2018 - Intelligent brains possess fewer neuronal connections, finds study
May 21, 2018 - UA physicians developing new tool to detect urethral blockage
May 21, 2018 - Fish-eating habits of pregnant women not linked to autistic traits in their children
May 21, 2018 - Shingrix Shingles Vaccination | What You Should Know
May 21, 2018 - Early depression diagnosis is deadly serious for patients with coronary artery disease
May 21, 2018 - Reducing exposure to hormone interfering chemicals may mitigate obesity risk
May 21, 2018 - Analysis of lymph node dissection shows no overall survival benefit in renal carcinoma patients
May 21, 2018 - FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine
May 21, 2018 - Infant death study reveals dangerous sleep practices among babysitters, relatives, others
May 21, 2018 - Intermittent fasting may increase diabetes risk, shows study
May 21, 2018 - Increase in local temperature correlates with higher degree of antibiotic resistance, finds study
May 21, 2018 - Treg infusions show promise in slowing progression of ALS
May 21, 2018 - New study shows declines in prostate cancer screening, diagnoses and treatment
May 21, 2018 - Fasting diets could raise risk of diabetes say experts
May 21, 2018 - FDA Alert: 7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall
May 21, 2018 - Cell phones at summer camp: Research explores the effects
May 21, 2018 - Birth rate decline driven by waiting longer to have children, cost of infertility treatment
Pfizer announces Phase 3 study results of LYRICA Oral Solution CV for pediatric epilepsy patients

Pfizer announces Phase 3 study results of LYRICA Oral Solution CV for pediatric epilepsy patients

image_pdfDownload PDFimage_print

Pfizer Inc. announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA at the lower dose (7 mg/kg/day) did not result in a statistically significant reduction in seizure frequency versus placebo. The study was a post-marketing requirement by the U.S. Food and Drug Administration (FDA). LYRICA is not approved as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

“The Phase 3 top-line results reinforce the efficacy and safety profile of LYRICA for pediatric epilepsy patients,” said James M. Rusnak, M.D., Ph.D., Chief Development Officer, Internal Medicine, Pfizer Inc. “These findings add to the data available for LYRICA in the pediatric patient population for a complex and difficult-to-treat condition.”

The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, four of which have been completed and two of which are actively enrolling.

About the Study

This Phase 3 study was a double-blind, placebo-controlled, randomized, parallel group, multi-center study that included 14 days of double-blind adjunctive treatment. In this study, 175 pediatric patients with partial onset seizures who were not adequately controlled with one to three concomitant antiepileptic drugs were enrolled from 52 centers in 22 countries. Patients were randomized to placebo, or one of two fixed doses of LYRICA divided three times daily: LYRICA 14 mg/kg/day or LYRICA 7 mg/kg/day in a 2:1:2 ratio.

The safety profile observed in this study is comparable to the known profile of LYRICA in prior epilepsy studies in pediatric and adult patients. No unexpected or new safety findings were reported in the pediatric patients with partial onset seizures in this study. The most common adverse events with LYRICA 14 mg/kg/day in this study were somnolence, upper respiratory tract infection, and pneumonia. The most common adverse events with LYRICA 7 mg/kg/day in this study were somnolence, upper respiratory tract infection, and pyrexia. The most common adverse events with placebo were upper respiratory tract infection, vomiting, somnolence, and pyrexia.

Complete study results are expected to be submitted for publication in a peer-reviewed medical journal. These data along with those of prior studies will be submitted to the FDA for LYRICA pediatric exclusivity determination.

Source:

https://www.pfizer.com/news/press-release/press-release-detail/lyrica_pregabalin_oral_solution_cv_phase_3_trial_in_pediatric_epilepsy_meets_primary_endpoint

Posted in: Child Health News | Drug Trial News

Tags: Alcohol, Angiotensin, Anxiety, Biopharmaceutical, Blood, Blood Vessel, Breastfeeding, Children, Consumer Health, Depression, Diabetes, Dialysis, Diarrhea, Doctor, Drugs, Enzyme, Epilepsy, Fibromyalgia, Frequency, Health Care, Heart, Hives, Kidney, Lyrica, Mortality, Muscle, Nausea, Neck, Nerve, Pain, Pfizer, Placebo, Pneumonia, Pregabalin, Research, Respiratory, Seizure, Shingles, Skin, Spinal Cord Injury, Tongue, Tumor, Vomiting

Tagged with:

About author

Related Articles