The application, use, and removal of the injector were found to be acceptable and 100% of subjects were likely to use the BD Libertas Wearable Injector if prescribed
This research to evaluate the performance of the 5 mL BD Libertas device in human subjects, including tissue effects, skin reactivity and patient acceptance, confirms that the BD Libertas device delivered within an acceptable time period 5 mL of 8 cP injections to the abdomen and thigh regardless of subject age, gender, or BMI and with/without patient movement.
The application, use, and removal of the injector were found to be acceptable and 100% of subjects were likely to use the BD Libertas Wearable Injector if prescribed. No severe wheal, erythema, or bleeding was observed, and no unacceptable pain was noted at 24 hours post-injection.
The study represents the most recent in a series of over 50 BD-conducted pre-clinical and clinical studies intended to inform the design and measure the performance of the BD Libertas Wearable Injector, demonstrate feasibility of 2-10 mL biologic injections into subcutaneous tissue and characterize tissue response to large volume injections in human and animal subjects.
“These results show that BD Libertas Wearable Injector effectively delivers dose volumes up to 5 mL subcutaneously and may be leveraged by our pharmaceutical partners as a reliable platform for large volume delivery,” said Eric Borin, Worldwide President, BD Pharmaceutical Systems. “BD is committed to working with our customers and the broader pharmaceutical market to meet their needs by enabling an expanded drug delivery design space. We are excited to share these results further with our partners and the broader market, to help accelerate and de-risk combination product development.”
Biologics for subcutaneous delivery in larger dose volumes (>2mL) are now being developed by pharmaceutical companies to support life cycle management of therapies, including migration from intravenous to subcutaneous routes of administration. BD undertook this study, recognizing that limited clinical evidence exists in the public domain to support injection feasibility and tolerability with wearable injector solutions to deliver larger dose volumes (up to 5 mL).
A detailed analysis of the BD independently sponsored and conducted study has been published in Clinical and Translational Science (5 Dec 2020).
BD Libertas Wearable Injector is a product in development; some statements are forward looking and are subject to a variety of risks and uncertainties. BD Libertas Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance.
Source: Company Press Release