Apiject Advances Injection Device Submission for FDA Approval
Apiject Submits Innovative Injection Device for FDA Approval
An Important Step Forward for the Improvement in Medical Care for Patients Worldwide.
Today, Apiject Systems, Corp. announced it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for its groundbreaking injectable medicine, which utilizes Apiject's prefilled, single-use plastic syringe. This submission marks a significant milestone in developing a new method of drug delivery.
The Technology Behind Apiject's Innovation
At the core of Apiject's NDA submission is a sophisticated drug delivery platform that combines two established technologies: Blow-Fill-Seal (BFS) liquid packaging and precision injection molding of needle hubs. This advanced combination facilitates the creation of scalable, affordable prefilled drug delivery devices compared to traditional glass vials and prefilled syringes.
BFS offers a continuous manufacturing process, leveraging a single type of raw material domestically sourced. As a result, it operates at exceptional speeds while maintaining low costs. Jay Walker, Co-Founder and Executive Chairman of Apiject, emphasizes the importance of BFS in facing modern healthcare challenges, reflecting the growing global demand for innovative medical injections.
Scaling Production and Meeting Healthcare Needs
Walker states, "Our submission is a crucial step. We aim to enhance domestic production capacity, improve flexibility, and decrease costs, thus meeting urgent healthcare needs both domestically and globally." The innovative approach Apiject adopts aims to create less carbon output than traditional solutions, making it an environmentally friendly choice.
BFS technology also allows for diverse container designs suitable for various medical applications, including injections, inhalants, eye drops, and more. The FDA's formal recognition of BFS as an advanced aseptic process further cements its credibility in the healthcare industry.
Partnerships and Collaborative Efforts
Apiject's success story is further evidenced by financial backing from the U.S. Department of Health and Human Services (HHS), amounting to approximately $181 million. This funding aims to build new domestic capacities that lessen reliance on foreign suppliers.
Moreover, Apiject has established strong public-private partnerships, collaborating with the U.S. Department of Defense to ensure a robust emergency fill-finish capacity for traditional injection materials. This collaborative approach has set a foundation for Apiject's growth and innovation.
Strategic Collaborations for Enhanced Production
To expand its production capabilities, Apiject has partnered with Amneal Pharmaceuticals, a reputable U.S.-based biopharmaceutical company. This collaboration aims to boost domestic production of Apiject’s BFS-based injectable platform, further solidifying its commitment to innovative patient solutions.
Future Prospects and Drug Applications
The company's technology background positions it favorably for future endeavors. Glycopyrrolate, the drug associated with the current NDA, will serve as an adjunctive therapy, significantly reducing acid production in patients. The Apiject device is aptly designed to accommodate various medications, paving the way for additional combination product filings likely to be announced in the coming years.
Dr. Molly Weaver, Chief Operating Officer and NDA Project Leader, highlights the intensive R&D efforts that have refined the BFS technology. Under the leadership of Marc Koska, known for inventing the K-1 auto-disabled syringe, the Apiject team has diligently worked towards a robust platform for drug administration.
Addressing Critical Health Challenges
Apiject is exploring new projects using its advanced technology, including a nasal delivery device filled with Naloxone aimed at combating opioid overdoses. As the opioid crisis persists, such innovations are crucial for public health.
About Apiject Systems, Corp
Apiject Systems, Corp. is dedicated to enhancing healthcare through innovative medical technology. With a focus on affordability and scalability, their prefilled injection devices aim to make high-quality drug delivery systems available worldwide. The company's established BFS technology serves as the backbone of its innovative solutions, ensuring safety and performance across diverse injection applications. For more information about Apiject's groundbreaking work, visit their website.
Frequently Asked Questions
What is Apiject's primary innovation in drug delivery?
Apiject's primary innovation is the development of a prefilled, single-use plastic syringe utilizing Blow-Fill-Seal technology to enhance drug delivery efficiency.
What are the advantages of Blow-Fill-Seal technology?
BFS technology allows for continuous manufacturing, reducing costs and carbon output while ensuring high speed and flexibility in drug container designs.
How does Apiject plan to improve domestic drug production?
Apiject aims to enhance domestic manufacturing capabilities through strategic partnerships and government support, reducing reliance on foreign suppliers.
What types of medications can be delivered using Apiject's device?
The device is designed to be drug agnostic, meaning it can be used for a variety of injectable medicines across different healthcare applications.
What is Apiject's mission?
Apiject's mission is to provide affordable prefilled injection solutions to improve patient access to injectable medicines and vaccines worldwide.
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