Fentanyl

PHILADELPHIA--(BUSINESS WIRE)--Instanosis Inc. today announced that its Xylazine Rapid Test (Urine) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), representing a significant milestone in the development of rapid diagnostic tools addressing emerging drug threats. Instanosis Receives FDA Breakthrough Device Designation for Its Xylazine Urine Rapid Test Xylazine, a veterinary sedative not approved for human use, has become increasingly prevalent in the illicit drug supply across the United States. It is frequently identified in combination with fentanyl and other synthetic opioids and has been associated with severe respiratory depression, prolonged sedation, and complex soft tissue injury. Because naloxone does not reverse the effects of xylazine, identifying its presence is critical for informing clinical assessment and patient monitoring. The Instanosis Xylazine Rapid Test (Urine) is designed to provide rapid detection of xylazine in urine samples. The device is intended to support healthcare providers, laboratories, and public health professionals in identifying potential exposure and improving awareness of evolving substance patterns. The FDA’s Breakthrough Device Designation program is intended to expedite the development and review of medical devices that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. Through this designation, Instanosis will receive prioritized interaction and review as the company advances the device through its regulatory pathway. “The FDA’s Breakthrough Device Designation is a significant milestone for our development program,” said Dr. Xiaofeng Xia, Chief Operating Officer of Instanosis. “This designation enables enhanced interaction with the Agency as we execute our clinical and regulatory strategy to deliver a reliable, rapid xylazine detection solution to the market.” Instanosis remains dedicated to building science-driven diagnostic technologies that address dynamic public health and clinical challenges in a rapidly changing healthcare environment. About Instanosis: Instanosis is a Pennsylvania-based diagnostics company committed to developing rapid testing technologies for use in clinical and community settings. The company advances innovative detection solutions designed to support healthcare providers, public health agencies, and frontline stakeholders nationwide.

Millennium Health Signals Report shows Illicit stimulant use increased virtually everywhere in the U.S. from 2024 to 2025 Clinicians are managing increasingly complex patterns of polysubstance use without adequate therapeutic tools.” — Angela Huskey, PharmD, CPE, Senior Vice President & Chief Clinical Officer SAN DIEGO, CA, UNITED STATES, February 17, 2026 / EINPresswire.com / -- After more than twenty years of rising fatal drug overdoses in the United States, new data show the most sustained national decline in overdose deaths in two decades. But according to the newly released Millennium Health Signals Report ® , Volume 8, the drug use landscape remains fluid—highlighted by the continued widespread rise of illicit stimulant use, which threatens to undercut recent progress. Drawing from more than 1.69 million clinical urine drug tests collected from 2016–2025, the report reveals meaningful declines in fentanyl detection beginning in 2023 that mirror national decreases in fentanyl-involved overdose deaths. However, the findings also illustrate persistent and accelerating increases in methamphetamine and cocaine use across the country. “The overdose crisis remains a humanitarian challenge as much as a public health one,” said Scott Walton, CEO of Millennium Health. “Even as we see encouraging declines in fentanyl-related deaths, the growing prevalence of stimulant use—and the clinical complexities that come with it—make clear that we must remain vigilant, adaptive, and deeply committed to supporting clinicians, researchers, public health officials, and policymakers who are working to save lives.” Key Findings from Millennium Health’s 2026 Signals Report Illicit Stimulant Use Continues to Surge Among People Who Use Fentanyl • In 2025, 85% of people testing positive for fentanyl also tested positive for an illicit stimulant—the highest proportion ever recorded in Millennium Health’s datasets. • Illicit stimulant use increased among people using fentanyl in all U.S. Census regions from 2024-2025, with fentanyl-methamphetamine co-use jumping 40.7% in the South and fentanyl-cocaine co-use rising 19.3% in the Northeast. • The detection of cocaine and methamphetamine together in the population using fentanyl grew in all U.S. Census regions, with triple digit increases in the West (249%), Northeast (239%), and South (154%) between 2020 and 2025. • In 2025, every U.S. state saw methamphetamine or cocaine detected more frequently than heroin or prescription opioids among people using fentanyl—a first in Millennium Health’s reporting history. Stimulant Use Is Rising Even in the Absence of Fentanyl Use • Among individuals not using fentanyl, methamphetamine detection increased 4.5% nationally in 2025, and cocaine detection rose 13.5%—with the South showing the steepest gains. Fentanyl Supply Remains Highly Volatile • Urine drug testing data showed significant drops in fentanyl detection in 2023–2024, followed by a rapid rebound in late 2024 into early 2025—mirroring overdose death data. • A spike in heroin and other opioid detections in mid 2024 suggests the occurrence of a potential fentanyl supply shock, consistent with recent reporting from multiple sources. The report underscores a growing gap between the scale of stimulant use and the clinical options available to treat stimulant use disorders—especially in the absence of FDA-approved medications. While contingency management remains the most effective evidence-based intervention, implementation barriers persist. “Clinicians are managing increasingly complex patterns of polysubstance use without adequate therapeutic tools,” said Angela Huskey, PharmD, CPE, Senior Vice President & Chief Clinical Officer. “Real-time drug testing insights are essential to guide care and inform policy—especially at a moment when the drug landscape continues to evolve so rapidly.” A copy of the full report can be accessed here. Methodology The 2026 Millennium Health Signals Report is an analysis of clinical urine drug testing specimens collected between January 1, 2016, and November 30, 2025. The specimens included were collected in health care practices located in all 50 states from patients aged 18 years or older with a substance use disorder diagnosis. More than 1.69 million urine specimens representing 530,000 unique patients were included in the analysis. Further detail on the drugs analyzed and statistical methods is provided in the report. About Millennium Health Millennium Health is an accredited specialty laboratory with over 15 years of experience in drug testing. We provide objective information about patients’ recent use of prescription medications and/or illicit drugs which helps clinicians monitor and treat millions of Americans living with chronic pain, substance use disorders, mental health disorders or other health conditions. Our ability to monitor drug use trends allows us to alert clinicians, health agencies and others to real-time drug use changes to help inform more targeted drug overdose prevention and response strategies to save lives. Aaron Cohen Millennium Health +1 301-633-6773 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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