Thumb is not needed. To flip off the cap, you do not need a thumb. Those with limited mobility can grip the injector and use the edge of a table to flip off the cap (this is what my cousin does or sometimes he can use both hands and twist it off with his other hand as well). View the video and see how the user grips the device. This is closer to reality than diagrams of a user who has full use of their thumbs.
Yes, the user guide shows animation using the thumb.
Medac has not conducted actual Human User Studies. [Otrexup is specifically designed to be used by RA patients who have moderate-to-severe hand function impairment, which is evidenced by the "Human Factors Usability Study" and "Actual Human Use Study" conducted by Antares.]
Medac conducted: "Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient" a Ph I study.
Medac conducted: "Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)" a Ph 3 study, "An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis"
Antares conducted: "Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device" a Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
Human Factors Usability Study for OTREXUP completed
• Actual Human Use Study completed
• Two Human Systemic Availability studies conducted including the
recently completed Systemic Availability Study
BD is a syringe/injector making shop on an industrial scale. The BD device is a syringe with a button for activation and an exposed needle and any company can call up BD and get their injector to use for their drug. This is what Medac did, they found a subQ injector that worked for their version then entered into a third party supplier (BD)agreement.
Yes, on paper the BD device is inferior to Antares device. And I think this come to light after Rasuvo actually gets into the market place.
