Breaking News
April 20, 2018 - FDA Alert: Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination
April 20, 2018 - What is heart failure?
April 20, 2018 - Inactivity of astronauts during spaceflights may have more pronounced effect on skeletal muscle than hypoxia
April 20, 2018 - New SIDS Info app seeks to reduce infant sleep-related deaths
April 20, 2018 - Wide-scale distribution of naloxone effectively prevents overdose deaths, study finds
April 20, 2018 - Triple-negative breast cancer found to be chemoresistant prior to treatment
April 20, 2018 - ACL tears occur the same way in women and men, study finds
April 20, 2018 - UT Southwestern researchers identify 170 potential therapeutic targets for lung cancer
April 20, 2018 - Finding the ‘keyhole’ to beat obesity at the cellular level
April 20, 2018 - Long-term exposure to cold temperatures reduces diabetes and obesity, shows study
April 20, 2018 - Metabolic Syndrome Common With Chronic Hep B Infection
April 20, 2018 - Tracking quality of life during prostate cancer treatment
April 20, 2018 - Study shows presence of beta-amyloid dimers in the brains of Alzheimer’s patients
April 20, 2018 - Researchers identify link between physical inactivity and increased risk of dying from cancer
April 20, 2018 - Breathtaking evolution amongst Indonesian tribe
April 20, 2018 - Study shows testosterone deficiency in men is associated with chronic diseases
April 20, 2018 - Simple one-page form helps improve satisfaction of patients with care
April 20, 2018 - Researchers evaluate accuracy of simple blood test to predict lung cancer
April 20, 2018 - Study looks at sperm producing ability in testicular cancer patients
April 20, 2018 - Exercise In, Vitamin D Out for Preventing Falls: U.S. Panel
April 20, 2018 - Skin cancers associated with decreased risk of developing AD
April 20, 2018 - Preserving fertility during chemotherapy
April 20, 2018 - Teva and Procter & Gamble Company terminate PGT Healthcare partnership
April 20, 2018 - People diagnosed with traumatic brain injury may have increased risk of Parkinson’s disease, shows study
April 20, 2018 - Researchers use smartphone to diagnose people infected with Loa loa worm
April 20, 2018 - College students with autism have high rate of suicidal thoughts
April 20, 2018 - Study sheds light on how the HSC niche is maintained
April 20, 2018 - Drug test spurs frank talk between hypertension patients and doctors
April 19, 2018 - Low-cost deworming drug improves female farmers’ physical fitness
April 19, 2018 - Genome editing identifies neural circuit behind leptin’s anti-obesity and anti-diabetes effects
April 19, 2018 - Many European countries lack comprehensive policy to eliminate viral hepatitis
April 19, 2018 - Young people with ADHD ‘more likely’ to come from deprived neighbourhoods
April 19, 2018 - SLU professor discovers new biomarkers for chlorine gas exposure
April 19, 2018 - Study proposes new mechanism that may contribute to gender differences in weight control
April 19, 2018 - Sleep restriction therapy does not interfere with insomnia patient’s driving ability, research shows
April 19, 2018 - Deep brain stimulation offers relief to UTHealth patient with treatment-resistant depression
April 19, 2018 - Study shows fatty fish and camelina oil boost HDL and IDL cholesterol
April 19, 2018 - FDA Alert: Euphoric Capsules by Epic Products: Recall
April 19, 2018 - Researchers identify peptide produced during cartilage deterioration as a potential source of osteoarthritis pain
April 19, 2018 - New breakthrough may allow scientists to orchestrate tissue regeneration in humans
April 19, 2018 - SYGNIS AG introduces new TruePrime apoptotic cell free DNA amplification kit
April 19, 2018 - Innovative device shows promise in capturing and releasing circulating tumor cells
April 19, 2018 - Researchers shed light on role of striosomal neurons in reinforcement learning
April 19, 2018 - Genetic make-up impacts long-term effectiveness of phobia treatment
April 19, 2018 - Novel biomarker can distinguish malignant lung nodules
April 19, 2018 - Study reports promising novel approach to treat therapy resistant pediatric brain tumors
April 19, 2018 - One-Hour Plasma Glucose Useful Predictor of Diabetic Retinopathy
April 19, 2018 - Hydroxychloroquine no more effective than placebo for relieving osteoarthritis hand pain
April 19, 2018 - Transplanted livers have a protective effect and reduce potential for organ rejection
April 19, 2018 - Researchers develop new method to study activity of inflammatory cells
April 19, 2018 - Researchers discover highly antibiotic resistant superbugs in Gulf States
April 19, 2018 - Smart-tooth technology shows promise in detecting certain diseases in high-risk patients
April 19, 2018 - Interaction between dioxin and HLA gene variant activates events associated with rheumatoid arthritis
April 19, 2018 - Eyes of adolescents could be associated with increased risk of cardiovascular disease in later life
April 19, 2018 - U.S. Women Less Likely Than Men to Get Statins After Heart Attack
April 19, 2018 - Health Canada grants cannabis cultivation license to High Park Farms
April 19, 2018 - Atypical brain development observed in preschoolers with ADHD symptoms
April 19, 2018 - SC Johnson releases annual Sustainability Report
April 19, 2018 - Positive attitudes about aging reduce risk of dementia in older adults
April 19, 2018 - Environmental pollutants found to worsen rheumatoid arthritis
April 19, 2018 - UT Southwestern scientists discover protein linked to metastatic breast cancer
April 19, 2018 - Study highlights need for further evidence to improve symptom management in end of life care
April 19, 2018 - Detecting diminished dopamine-firing cells inside brain could reveal earliest signs of Alzheimer’s
April 19, 2018 - Uniqsis offers high-power LED light unit for scalable flow photochemistry reactions
April 19, 2018 - Case study shows how intravascular ultrasound imaging helps detect acute aortic syndrome
April 19, 2018 - Research reveals new mechanism by which HIV evades the immune system
April 19, 2018 - Nanodisc-delivered cancer treatment helps eliminate tumors
April 19, 2018 - Functional connectivity MRI could help detect brain disorders and diseases
April 19, 2018 - Finding better way to quantify neuropathy symptoms and treatment efficacy
April 19, 2018 - Study examines effectiveness of caregiver education about sickle cell trait
April 19, 2018 - High-resolution images of tumor vasculature using new technology
April 19, 2018 - Lack of sleep may be linked to risk factor for Alzheimer’s disease
April 19, 2018 - Study finds neurotransmitter may play a role in alcohol relapse, addiction
April 19, 2018 - Researchers build molecular networks of calcific aortic valve disease
April 19, 2018 - Researchers develop highly specific apoptosis assay for pharmacodynamic analyses of tumor specimens
April 19, 2018 - Scientists decipher mechanism of chemotherapy induced female infertility
April 19, 2018 - New insight may allow researchers to design drugs that improve immune responses to vaccines
April 19, 2018 - FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
April 19, 2018 - Researchers uncover origin of virus-fighting plasma B cells
April 19, 2018 - Study finds no evidence of lower intelligence in young children who had anesthesia
INSYS Therapeutics Initiates Phase 3 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Infantile Spasms

INSYS Therapeutics Initiates Phase 3 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Infantile Spasms

image_pdfDownload PDFimage_print

PHOENIX, March 02, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced the initiation of a Phase 3 clinical trial to study cannabidiol (CBD) oral solution for the treatment of infantile spasms, a rare type of pediatric epilepsy that occurs in very young children, with the first trial site’s activation.

“We need better treatments for infantile spasms, one of the more severe and dangerous seizure disorders of early childhood,” said Shaun Hussain, M.D., a pediatric neurologist at UCLA Mattel Children’s Hospital and director of its Infantile Spasms Project. “That’s why we’re excited about this pivotal study, which has the potential to reveal a new piece of the treatment puzzle for infantile spasms.”

In previous studies, CBD—one of the main molecules in cannabis—has demonstrated sustained clinical benefits in a variety of medically refractory pediatric epilepsies, including infantile spasms, an uncommon condition estimated by the Child Neurology Foundation (CNF) to be diagnosed in about 1,200 children in the United States each year.

“We have great hope in the potential of our proprietary formulation of pharmaceutical-grade, synthetically manufactured CBD oral solution in combination with vigabatrin to offer greater seizure control to children with infantile spasms,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “The need for more efficacious and better tolerated products to treat this devastating disorder continues to motivate us to advance this investigational therapy through the clinical and regulatory pathway.”

According to the Infantile Spasms Action Network (ISAN), a collaborative advocacy network of 25 national and international organizations convened by CNF, infantile spasms have an average age of onset of around four months, although in some cases the first seizure occurs as early as one month or as late as two years. In most cases, infantile spasms appear to be slight head drops, which belie the seriousness of the condition. Evidence shows that infantile spasms are a more serious seizure disorder than generalized convulsions.

INSYS Therapeutics recently became a member of ISAN, which hosts an annual awareness and education initiative, Infantile Spasms Awareness Week (ISAW), held Dec. 1–7.

About INSYS

INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.

Forward-Looking Statements

This news release contains forward-looking statements including our belief regarding the potential of our investigational CBD oral solution to become an effective treatment for infantile spasms. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2016 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

Source: Insys Therapeutics, Inc.

Posted: March 2018

Tagged with:

About author

Related Articles