PHARMACY MARKET
businesswire | September 26, 2023
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.
“Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.”
Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.
ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet).
In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology.
“Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.”
About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.
About KYE Pharmaceuticals
Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.
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Business Insights, PHARMA TECH
PRNewswire | July 19, 2023
Endo International plc announced that its Par Sterile Products business has begun shipping bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial. It is the only ready-to-use liquid format of bivalirudin on the market in the U.S.
"Hospital practitioners work hard to provide quality patient care while also meeting operational challenges," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care."
In May 2023, Endo executed agreements with MAIA Pharmaceuticals, Inc. and Gland Pharma Limited, India to commercialize ready-to-use bivalirudin in the U.S. The product, manufactured by Gland Pharma Limited, is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots. It is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing an angioplasty procedure.
Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care
DRUG INTERACTIONS
In clinical trials in patients undergoing percutaneous coronary intervention (PCI), co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPls was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications.
USE IN SPECIFIC POPULATIONS
Geriatric Use
In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients.
Renal Impairment
The disposition of bivalirudin was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis- dependent patients. The infusion dose of bivalirudin injection may need to be reduced, and anticoagulant status monitored in patients with renal impairment.
INDICATION AND USAGE
Bivalirudin injection is indicated for use as an anticoagulant in patients undergoing PCI, including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
About Endo
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.
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Pharmacy Market
Businesswire | August 18, 2023
Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, today announced the first collaboration in the Koneksa Academic Partnership Program for Parkinson’s Disease (KAPP-PD) to incorporate its Neuroscience Toolkit into research programs.
The first collaboration of the KAPP-PD program, with Oregon Health & Science University (OHSU), enables the inclusion of app-and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments from Koneksa’s Neuroscience Toolkit into a study comparing short-acting versus long-acting levodopa in Parkinson’s disease. Koneksa’s Neuroscience Toolkit implements a variety of digital assessments that can be combined to collect data for measures of interest.
The OHSU team, led by Dr. Delaram Safarpour, MD, MSCE, FAAN, is investigating changes in the neurophysiological correlates of PD with carbidopa-levodopa immediate release compared to long-acting levodopa (Rytary), as well as changes in gait performance at intervals of 30 minutes for a total of 4 hours during each visit. This research will provide strong support for clinical profiles of short- versus long- acting levodopa in PD corresponding to objective physiological measures.
“We are collaborating with Koneksa to enhance our study’s objectives: We’ll be including smartphone- and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments into our study,” said Martina Mancini, Ph.D., co-investigator of the study, director of the Balance Disorders Laboratory, and Associate Professor of Neurology, OHSU School of Medicine. “Our lab uses new technologies to better understand and measure motor impairments, with the goal of learning how to better help patients with these conditions. Novel, objective metrics, like those made possible with Koneksa’s technology and toolkit, allow us to expand upon what we’ve been able to do in the clinic. In particular, digital at-home measures of daily physical activity, gait and mobility, motor functionality, sleep, and ePRO measures of quality of life all have the potential to uniquely complement OHSU’s in-clinic assessments, offering new and real-world-setting patient insights to support the study’s objectives.”
“Koneksa is proud to extend our contribution to critical neuroscience research through KAPP-PD, and we’re delighted to get the program underway with our first collaboration,” said John Wagner, MD, Ph.D., Chief Medical Officer, Koneksa. “These measures will support OHSU in both in-clinic and at-home patient monitoring of critical parameters of interest for this study. We’re committed to helping to get new and better treatments to patients faster, and that’s a vision that OHSU’s Balance Disorders Laboratory shares.”
About the Koneksa Academic Partnership Program – Parkinson’s Disease
The Koneksa Academic Partnership Program – Parkinson’s Disease (KAPP-PD) is a structured collaboration between Koneksa and select academic partners that enables researchers to incorporate Koneksa’s Neuroscience Toolkit into research programs focusing on Parkinson’s disease. Researchers gain access to an array of devices that capture key measures objectively and sensitively, as well as training materials for site coordinators and study subjects, a cloud-based platform for real-time monitoring, and industry-leading analytics and patented algorithms.
About Koneksa
Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes.
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