ANI Pharma starts Phase 4 trial of Cortrophin Gel for gout flares

Addressing a Serious, Painful Condition

“Gout is a chronic disease that affects millions, causing painful flares and temporary disability,”
– Dr. Hyon Choi, Principal Investigator, Rheumatology Unit at MGH
Dr. Choi emphasized the need for new treatment options, especially for patients who do not respond adequately to traditional anti-inflammatory therapies. He is a globally recognized expert in gout research and directs the MGH Gout & Crystal Arthropathy Center and co-directs the G-CAN Network.

About the Study

The Phase 4 trial is a:

Randomized, single-center, double-blind, single-dose study
Comparing 40 USP units/0.5 mL vs. 80 USP units/mL of Cortrophin Gel
Targeting patients with acute gout flares unresponsive to NSAIDs or colchicine
Enrolling up to 160 patients, with 70 evaluable patients per dose group for the primary endpoint

Key Objectives

Primary Endpoint

Change in gout pain intensity in the target joint at Day 3 post-administration, measured by the Visual Analog Scale (VAS)
Secondary Endpoints

Pain intensity changes at Days 1, 2, and 7
Time to onset of effect and time to response
Use of rescue medication
Patient and physician assessments of response
Safety and tolerability
Exploratory Endpoints

Impact on inflammatory biomarkers
Health-related quality-of-life outcomes
Healthcare resource utilization
Cortrophin Gel will be administered as a single subcutaneous or intramuscular injection, followed by a 7-day follow-up period with patient-reported outcomes.

Building the Evidence for Cortrophin Gel

“This is our first clinical trial dedicated to gout and a major step in strengthening the clinical evidence supporting Cortrophin Gel,”
– Dr. Mary Pao, Chief Medical Officer, Rare Disease, ANI Pharmaceuticals
Dr. Pao emphasized the study’s aim to provide meaningful data to guide physicians on optimal dosing for gout flare management.

Commitment to Access and Innovation

“We’ve seen increased use of Cortrophin Gel since launching our 1-mL vial in October 2023,”

 Nikhil Lalwani, President and CEO, ANI Pharmaceuticals
The smaller vial was introduced to improve in-office treatment access, and this trial is expected to further inform clinical use and support patients and providers in managing acute gout flares effectively.

About Cortrophin Gel

A prescription biologic therapy
Administered subcutaneously or intramuscularly
Indicated for short-term adjunctive treatment during acute gouty arthritis episodes
Contraindicated for intravenous administration

About ANI Pharmaceuticals

ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company dedicated to its mission of:

“Serving Patients, Improving Lives”
The company develops, manufactures, and commercializes innovative and high-quality therapeutics focused on rare and niche disease areas

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