Bio-equivalence of IM and SQ H.P. Acthar Gel.
OBJECTIVE
IM Acthar Gel (Acthar) is a natural-source ACTH used for the treatment of MS exacerbations. It is not known if subcutaneous (SQ) administration of Acthar is equivalent to IM administration or if lower doses of Acthar would provide comparable serum cortisol responses.


METHODS
We compared IM and SQ administration of Acthar to explore bio-equivalency between the two routes of administration.


RESULTS
Our results show that SQ administration of Acthar is bio-equivalent to IM administration. Both 20 and 80 units of Acthar, respectively, show bio-equivalency after SQ and IM administration. However, 20 units of Acthar do not provide comparable stimulation of the adrenal cortex compared to 80 units, administered either SQ or IM.


CONCLUSIONS
Bio-equivalency between IM and SQ administration may allow the use of SQ Acthar.
Brod
Staley Armstrong
SA
Department of Neurology, University of Texas-Houston, Health Science Center (UTHHSC), Houston, TX 77030, USA.
Morales
Miriam M
MM
D000324:Adrenocorticotropic Hormone / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000328:Adult; D005260:Female; D005782:Gels; D006801:Humans; D006854:Hydrocortisone / Q000097:blood / Q000378:metabolism; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy*; D013810:Therapeutic Equivalency
D005782:Gels; D000324:Adrenocorticotropic Hormone; D006854:Hydrocortisone