ANI Pharmaceuticals announced the receipt of clinical data on Cortrophin® Gel (80 units/mL) from a study that evaluated the blood-level cortisol response in a 20-person healthy volunteer population.
Key results:
- ANI's Cortrophin® Gel (80 units/mL) is effective for its intended use
- In addition, the clinical data demonstrate that ANI's modernized Cortrophin® Gel (80 units/mL) drug product has a cortisol response profile consistent with that observed in historical scientific literature that evaluated Cortrophin® Gel (44 units/mL) drug product manufactured in the 1960s
- No adverse safety events to be reported and minor events were as expected
"These results represent a significant milestone for ANI in our re-commercialization effort for Cortrophin® Gel,” Arthur S. Przybyl, ANI's President and CEO said. “In conjunction with our positive results in process and product characterization at commercial scale, method development and validation, release of clinical material and viral clearance, I believe this study demonstrates that we have successfully reproduced the Cortrophin® Gel drug previously manufactured in the 1990s. As such, I believe we will have an approvable drug product. We are excited to submit the Cortrophin® Gel comprehensive supplemental NDA filing currently planned for March 2020."
Cortrophin® Gel is purified corticotropin (ATCH) manufactured in sterile gelatin to allow prolonged activity. The product stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.