– Findings from nine human factors studies, assessing design and user interface, suggest SelfJect functions as an effective delivery device when used as intended 1 – – The SelfJect delivery device received the Arthritis Foundation's Ease of Use certification – DUBLIN , Sept. 17, 2024 /PRNewswire/ -- Mallinckrodt plc , a global specialty pharmaceutical company, today announced the publication of findings from seven formative and two validation human factors studies of recently launched Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJectTM Injector ("SelfJect"). 2 The manuscript, describing the formative and human factor outcomes, was recently published online in Expert Opinion on Drug Delivery .
Approved by the U.S. Food and Drug Administration (FDA) in February of 2024, SelfJect also received the Arthritis Foundation's Ease of Use ® certification.
This certification recognizes SelfJect for its easy-to-use design, based on testing by an independent third party. Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides. 2 Acthar Gel is approved by the FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.
2 SelfJect is available in 40 USP units/0.5 mL and 80 USP units/1.0 mL injectors and must be administered by people 18 years of age or older.
SelfJect is not to be used for the treatment of infantile spasms. Please see Indic.