Monday, August 18, 2014 1:13:56 PM
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.
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