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ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA
ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

Yahoo

time16-06-2025

  • Health
  • Yahoo

ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

SHANGHAI, June 15, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstarys (serdexmethylphenidate/dexmethylphenidate extended-release capsules) and granted it Priority Review designation. The investigational therapeutic drug is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged six years and above. First Methylphenidate Combination Drug Poised to Benefit Patients in China Azstarys (AK0901) is the first and currently the sole globally approved ADHD combination therapeutic pairing immediate-release dexmethylphenidate (d-MPH) with the prodrug serdexmethylphenidate (SDX). Approved by the U.S. FDA in 2021, Azstarys represents a new generation of methylphenidate medications, providing a dual-phase release profile that offers both rapid onset and sustained symptom control. This novel formulation sets a new benchmark in the management of ADHD for safety, efficacy, and convenience of administering for patients, making it a potential best-in-class ADHD therapeutic drug. Pharmacokinetic Property: Biphasic Release for Rapid Onset and Whole-Day Symptom Control Rapid onset: Immediate-release d-MPH ensures symptom relief within 30 minutes, offering fast control over core ADHD symptoms. Extended control: SDX is metabolized slowly into d-MPH in intestine over time, ensuring up to 13 hours of therapeutic effect with reduced risk of evening rebound symptoms. Stable Release Profile: Designed to support the full span of a patient's day—from school or work to evening activities—Azstarys enhances adherence and minimizes sleep disruptions, suiting both pediatric and adult populations. Abuse-Deterrent Design Azstarys incorporates an inherent abuse-deterrent design through the inclusion of SDX, which undergoes slow conversion in the gastrointestinal tract. This limits peak plasma concentrations of d-MPH and significantly reduces the potential for misuse via non-oral routes—a key public health consideration in ADHD pharmacotherapy. Robust Clinical Efficacy and Safety Confirmed in China Phase III Trial In a multicenter Phase III trial spanning eight leading clinical hospitals in China, Azstarys demonstrated statistically significant improvements over placebo in primary and secondary efficacy endpoints. The study reported no drug related serious adverse events, affirming Azstarys's favorable safety and tolerability profile, critical for long-term use in pediatric settings. Transforming ADHD Treatment Paradigm in China As the third-generation methylphenidate therapy, Azstarys delivers a new standard of care in ADHD management by integrating rapid onset and full-day symptom control into a single dose. Its future approval in China would mark the introduction of the first ADHD combination medication to the market, offering a better option for patients, families, and physicians. Dr. Jim Wu, CEO of ArkBio, stated, "The acceptance of Azstarys' NDA and its designation for Priority Review by the NMPA reflect regulatory authority's favorable opinions in our science and clinical study results. ADHD remains critically underserved in China, and Azstarys is designed to directly meet the needs of patients who require both immediate symptom relief and sustained control. We are grateful to our investigators, trial participants, collaborators, and the NMPA for this milestone and we look forward to accelerating access to this important therapeutic in China market." Azstarys® is a registered trademark of Corium, LLC in the United States. About ArkBio ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and Azstarys (AK0901), an FDA-approvedADHD therapeutic drug. ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions. For more information about the company, please visit our website: View original content to download multimedia: SOURCE Arkbio Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA
ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

Yahoo

time16-06-2025

  • Health
  • Yahoo

ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

SHANGHAI, June 15, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstarys (serdexmethylphenidate/dexmethylphenidate extended-release capsules) and granted it Priority Review designation. The investigational therapeutic drug is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged six years and above. First Methylphenidate Combination Drug Poised to Benefit Patients in China Azstarys (AK0901) is the first and currently the sole globally approved ADHD combination therapeutic pairing immediate-release dexmethylphenidate (d-MPH) with the prodrug serdexmethylphenidate (SDX). Approved by the U.S. FDA in 2021, Azstarys represents a new generation of methylphenidate medications, providing a dual-phase release profile that offers both rapid onset and sustained symptom control. This novel formulation sets a new benchmark in the management of ADHD for safety, efficacy, and convenience of administering for patients, making it a potential best-in-class ADHD therapeutic drug. Pharmacokinetic Property: Biphasic Release for Rapid Onset and Whole-Day Symptom Control Rapid onset: Immediate-release d-MPH ensures symptom relief within 30 minutes, offering fast control over core ADHD symptoms. Extended control: SDX is metabolized slowly into d-MPH in intestine over time, ensuring up to 13 hours of therapeutic effect with reduced risk of evening rebound symptoms. Stable Release Profile: Designed to support the full span of a patient's day—from school or work to evening activities—Azstarys enhances adherence and minimizes sleep disruptions, suiting both pediatric and adult populations. Abuse-Deterrent Design Azstarys incorporates an inherent abuse-deterrent design through the inclusion of SDX, which undergoes slow conversion in the gastrointestinal tract. This limits peak plasma concentrations of d-MPH and significantly reduces the potential for misuse via non-oral routes—a key public health consideration in ADHD pharmacotherapy. Robust Clinical Efficacy and Safety Confirmed in China Phase III Trial In a multicenter Phase III trial spanning eight leading clinical hospitals in China, Azstarys demonstrated statistically significant improvements over placebo in primary and secondary efficacy endpoints. The study reported no drug related serious adverse events, affirming Azstarys's favorable safety and tolerability profile, critical for long-term use in pediatric settings. Transforming ADHD Treatment Paradigm in China As the third-generation methylphenidate therapy, Azstarys delivers a new standard of care in ADHD management by integrating rapid onset and full-day symptom control into a single dose. Its future approval in China would mark the introduction of the first ADHD combination medication to the market, offering a better option for patients, families, and physicians. Dr. Jim Wu, CEO of ArkBio, stated, "The acceptance of Azstarys' NDA and its designation for Priority Review by the NMPA reflect regulatory authority's favorable opinions in our science and clinical study results. ADHD remains critically underserved in China, and Azstarys is designed to directly meet the needs of patients who require both immediate symptom relief and sustained control. We are grateful to our investigators, trial participants, collaborators, and the NMPA for this milestone and we look forward to accelerating access to this important therapeutic in China market." Azstarys® is a registered trademark of Corium, LLC in the United States. About ArkBio ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and Azstarys (AK0901), an FDA-approvedADHD therapeutic drug. ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions. For more information about the company, please visit our website: View original content to download multimedia: SOURCE Arkbio

Is There an Azstarys Shortage?
Is There an Azstarys Shortage?

Health Line

time09-06-2025

  • Health
  • Health Line

Is There an Azstarys Shortage?

Azstarys is a prescription drug used to treat ADHD. Some ADHD medications have recently been in short supply. Learn whether Azstarys is affected and how to check its availability. Azstarys is not currently listed in the Food and Drug Administration (FDA) drug shortages database. Here's what to know about why some ADHD medications may be hard to find and how to check for drug shortages. Is there a shortage of other ADHD drugs? In recent years, several ADHD medications have been in short supply. A few examples include Adderall, Concerta, Ritalin, and Vyvanse. It's not yet clear when these shortages will fully resolve. These shortages have affected both brand-name and generic versions of the drugs. As a result, some people have worked with their doctor to switch to a different medication or adjust their ADHD treatment plan. To check the current status of Aztarys and other ADHD medications, visit the FDA drug shortages website. How do ADHD drug shortages affect people? Shortages of ADHD medications can make it harder for people to stick with their treatment plan. This can cause ADHD symptoms to return or become more difficult to manage. A lack of consistent access to ADHD medication may also increase stress and affect mental health. Other possible effects of disrupted access to ADHD medication include: difficulty focusing or completing daily tasks increased impulsivity or emotional outbursts difficulty falling or staying asleep withdrawing from social, family, or work activities If you're having trouble filling a prescription for an ADHD medication, talk with your doctor or pharmacist. They may recommend alternatives or adjust your treatment plan based on what's available. What causes a drug shortage? Several factors can lead to a medication being in short supply. Common causes of ADHD drug shortages include: Increased demand: More people receiving diagnoses of ADHD have led to greater demand for medications. This can strain manufacturers and reduce availability at pharmacies. Regulatory limits: Stimulant medications used to treat ADHD, including Azstarys, are controlled substances. The Drug Enforcement Administration (DEA) sets yearly production limits for these medications. If demand rises suddenly, these limits may contribute to shortages. Supply chain issues: Shortages of raw materials, packaging supplies, or labor can delay the manufacturing and availability of ADHD drugs. When multiple ADHD medications are in short supply at the same time, it can be especially hard for pharmacies to keep any option in stock. Even when generic forms are available, they may be affected by the same issues as brand-name drugs. As a result, generics may be just as difficult to find during a shortage. How can I check whether Azstarys is available near me? Azstarys is not currently listed by the FDA as being in shortage. However, some people may still experience delays when trying to fill their prescription. Availability can vary depending on your pharmacy, location, and insurance plan. If you're having trouble finding Azstarys, start by talking with a pharmacist. If possible, visit the pharmacy in person. Some pharmacies may not share inventory details for ADHD medications over the phone. You can also check pharmacy websites or apps, which sometimes offer tools to look up availability online. Keep in mind that availability may change as new shipments arrive. You can also check with your insurance provider. If Azstarys isn't available through your plan's preferred pharmacy, your insurer may be able to help you locate another pharmacy. In some cases, you may want to reach out to the drug manufacturer for information about availability in your area. To learn more about contacting the manufacturer, visit the Azstarys website.

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