ANI Announces Positive Clinical Results from Cortrophin® Gel Cortisol Response Study
BAUDETTE, Minn., Oct. 3, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the receipt of clinical data on CortrophinGel (80 units/mL) from a study that evaluated the blood-level cortisol response in a 20-person healthy volunteer population.
- BAUDETTE, Minn., Oct. 3, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the receipt of clinical data on CortrophinGel (80 units/mL) from a study that evaluated the blood-level cortisol response in a 20-person healthy volunteer population.
- The results indicate that 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 (Brombacher et.
- 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.