Latest news with #Kye
Cision Canada
7 days ago
- Health
- Cision Canada
Kye Pharmaceuticals Announces the Approval of DYANAVEL® XR (amphetamine extended-release) Tablets and Oral Suspension for the Treatment of Adults and Children With ADHD Français
MISSISSAUGA, ON, Aug. 5, 2025 /CNW/ - Kye Pharmaceuticals Inc. ("Kye"), a leading Canadian-based commercial-stage specialty pharmaceutical company focused on licensing and commercializing innovative medicines for patients in Canada, is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel ® XR (amphetamine extended-release) tablets and oral suspension. Dyanavel ® XR is indicated for the treatment of ADHD in adults 18 years of age and over as well as in children aged 6-12 years old. 1 Dyanavel ® XR is a long-acting psychostimulant. These types of treatments for ADHD are recommended as first line by the Canadian ADHD resource alliance (CADDRA) guidelines. 2 Attention Deficit Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder leading to impairments in learning and behaviour. ADHD affects approx. 3-5% of adults and 5-9% of children and adolescents 3. Patients with ADHD experience difficulties regulating their attention or focus. Dr. Sam Chang MD, FRCPC, Child and Adolescent Psychiatrist, Clinical Associate Professor, University of Calgary "ADHD is a complex neuro-developmental condition. The goal of treatment is having the patient realize their full potential. Dyanavel ® XR will provide an important new option for HCPs to optimize ADHD treatment in Adults and Children." Dr. Ghalib Ahmed MD, CCFP,FCFP, Assistant Clinical Professor-University of Alberta, Faculty of Medicine, General Practitioner-Chokka Centre, Secretary- CADDRA Board "Every person and family affected by ADHD deserves access to treatment options that reflect their unique journeys, needs, challenges, and goals." John McKendry, President and CEO of Kye Pharmaceuticals "Dyanavel ® XR, developed using the novel LiquiXR ® extended-release delivery technology is the first and only extended-release oral suspension and chewable tablet amphetamine approved in Canada. Alongside our recent launches of Quillivant ® ER Oral Suspension and Chewable Tablets, our team has the privilege of supporting the most extensive portfolio of branded ADHD medicines in Canada." About ADHD ADHD is a chronic neurodevelopmental disorder leading to impairments in learning and behaviour. ADHD affects approx. 3-5% of adults and 5-9% of children and adolescents 3. Patients with ADHD experience difficulties regulating their attention or focus. According to the Centre for ADHD Awareness, Canada (CADDAC), 50-80% of children diagnosed with ADHD continue to qualify for a diagnosis in adolescence and at least 65% continue to be impaired by symptoms in adulthood. 3,4 About Dyanavel ® XR - Tablets and Oral suspension Dyanavel ® XR (amphetamine, extended-release) - Tablet and Oral suspension is approved in Canada for the treatment of ADHD in children six to 12 years of age as well as in adults over the age of 18. The onset of action is significant at one hour post dose with a duration of therapy of 13 hours for both formulations. 1 DYANAVEL ® XR has a tablet and oral suspension formulations that use a drug delivery technology called LiquiXR ® made up of resin bound uncoated immediate-release drug and extended-release drug with variable coating. The combination of free drug, resin-bound uncoated drug and resin bound coated drug with variable thickness coating results in continuous release of amphetamine. This technology was developed by Tris Pharma. Dyanavel ® XR tablets can be chewed or swallowed. About Kye Pharmaceuticals Kye, headquartered in Toronto, is a leading growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada. With a growing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas including cardiology, psychiatry, pediatrics, rare diseases, neuromuscular, hematology, and neurology. Kye Pharmaceuticals is a private company, founded in Canada and focused exclusively on the healthcare needs of patients in Canada. Kye aims to provide medicines that deliver better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information, please visit Dyanavel XR (amphetamine extended-release) Oral Suspension and Tablets. Product Monograph. Kye Pharmaceuticals Inc., Mississauga, ON. CADDRA - Canadian ADHD Resource Alliance: Canadian ADHD Practice Guidelines, 4.1 Edition, Toronto ON; CADDRA, 2020. Available at (Accessed July 2025) (Accessed July 2025) (Accessed July 2025) SOURCE Kye Pharmaceuticals Inc.
Cision Canada
18-06-2025
- Business
- Cision Canada
Kye Pharmaceuticals Receives Health Canada Approval for New Dosing Guidance for FIRDAPSE ® and an additional Pediatric Indication Français
MISSISSAUGA, ON, June 18, 2025 /CNW/ - Kye Pharmaceuticals, Inc. ("Kye") today announced that Health Canada has approved its SNDS (Supplemental New Drug Submission) regarding the recommended dosage of FIRDAPSE® (amifampridine) for adults to include that some patients may benefit from a total daily dose of 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The direction that some patients may benefit from an increased maximum daily dose of up to 100 mg offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS. The expanded indication includes pediatric dosing guidance for patients 6 years of age and older and offers pediatric neurologists a proven treatment option for children diagnosed with LEMS. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. FIRDAPSE is a potassium channel blocker indicated for the treatment of LEMS in adults and pediatric patients and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS. This approval expands the approved dosing options for prescribers treating LEMS as well as broadening the indication to include pediatric patients. "We are pleased to receive the approval for both the additional guidance that some patients may benefit from an increased maximum daily dose of FIRDAPSE as well as the pediatric indication starting at age six," said John McKendry, President and CEO of Kye Pharmaceuticals. "This expanded label highlights our continued commitment to the LEMS community in Canada. We believe that this label update will have meaningful impact on the lives of LEMS patients across Canada and will help to improve patient outcomes." About Kye Pharmaceuticals Kye Pharmaceuticals is a growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada. With a growing pipeline of novel medicines, Kye's portfolio spans a range of therapeutic areas, including cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. Kye Pharmaceuticals is a private company headquartered in Toronto focused on bringing medications to the Canadian market which fulfill clinically significant unmet needs. Kye is committed to licensing and launching medicines that matter by delivering better outcomes to our partners, Canadian healthcare professionals, and, most importantly, patients across Canada.
Sky News
28-04-2025
- Climate
- Sky News
Blackouts latest: 'Rare atmospheric phenomenon' behind huge outages in Portugal and Spain
There are widespread reports that many across Spain and Portugal have been left without running water, with many homes given access to drinking water via electric pumps - which have obviously been affected by the power outage. Several people have been in touch to say they've seen people "panic buying" water and other supplies in supermarkets across Portugal and Spain. Kye, who's in Foros de Amora to the south of Lisbon, says people rushed for cheap still water at first, but are now turning to take sparkling and expensive brands. He shared these images from his local supermarket... It's a similar situation across the border. Keith tells us that queues at the Carrefour in Estepona, near Malaga, are lengthening as people rush to buy water and other essentials. Alison says "It's like COVID times again in the Algarve. Massive queues for fuel, and no water or toilet rolls in the supermarkets!"
Sky News
28-04-2025
- Climate
- Sky News
Blackouts latest: 'Rare atmospheric phenomenon' behind outages, Portuguese operator says
There are widespread reports that many across Spain and Portugal have been left without running water, with many homes given access to drinking water via electric pumps - which have obviously been affected by the power outage. Several people have been in touch to say they've seen people "panic buying" water and other supplies in supermarkets across Portugal and Spain. Kye, who's in Foros de Amora to the south of Lisbon, says people rushed for cheap still water at first, but are now turning to take sparkling and expensive brands. He shared these images from his local supermarket... It's a similar situation across the border. Keith tells us that queues at the Carrefour in Estepona, near Malaga, are lengthening as people rush to buy water and other essentials. Alison says "It's like COVID times again in the Algarve. Massive queues for fuel, and no water or toilet rolls in the supermarkets!"
Sky News
28-04-2025
- Climate
- Sky News
Blackouts latest: 'Rare atmospheric phenomenon' behind outage and disruption could last a week, Portuguese operator says
There are widespread reports that many across Spain and Portugal have been left without running water, with many homes given access to drinking water via electric pumps - which have obviously been affected by the power outage. Several people have been in touch to say they've seen people "panic buying" water and other supplies in supermarkets across Portugal and Spain. Kye, who's in Foros de Amora to the south of Lisbon, says people rushed for cheap still water at first, but are now turning to take sparkling and expensive brands. He shared these images from his local supermarket... It's a similar situation across the border. Keith tells us that queues at the Carrefour in Estepona, near Malaga, are lengthening as people rush to buy water and other essentials. Alison says "It's like COVID times again in the Algarve. Massive queues for fuel, and no water or toilet rolls in the supermarkets!"
