Purified Cortrophin Gel is the only ACTH therapy approved by the FDA for the treatment of acute gout flares

 ANI Pharmaceuticals, announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safety and efficacy of two dose levels (40 USP units and 80 USP units) of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) for the treatment of acute gout flares. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration. For additional important safety information, please see below.

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“Gout is a chronic disease that affects millions of patients, including acute flares that can cause extreme pain and temporary disability,” said Hyon Choi, MD, DrPH, principal investigator of the study and clinical investigator and physician in the Rheumatology Unit at Mass General Research Institute/Massachusetts General Hospital. “For some patients, conventional anti-inflammatory treatments do not provide adequate relief from these flares. We look forward to initiating this dose-ranging study, which we believe will provide valuable scientific information about Cortrophin Gel in the treatment of acute gout flares.”

Dr. Choi has been a leading physician investigator with a primary focus on gout and other inflammatory arthritic conditions throughout his academic career. He has authored more than 150 gout-related peer-reviewed papers in leading journals, and his findings have been referenced by many articles as well as guidelines from the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Dr. Choi directs the MGH Gout & Crystal Arthropathy Center and co-directs the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN), a non-profit organization dedicated to creating research and education initiatives to fill the knowledge gap in gout.

“This Phase 4 study in gout is the first clinical trial launched by ANI as part of our commitment to building the scientific evidence and clinical data supporting the use of Cortrophin Gel,” said Mary Pao, MD, PhD, Chief Medical Officer of Rare Disease at ANI. “Our goal with the study is to generate meaningful clinical information for the dosing of Cortrophin Gel in patients with acute gout flares by comparing the safety and efficacy of two dose levels of the product. We believe this study will provide physicians with more data to inform their approach to patient care.”

“We have seen steady growth in the use of Cortrophin Gel as an adjunctive therapy for gout flares since we launched our 1-mL vial, which we developed to help increase access for in-office treatment, in October 2023,” said Nikhil Lalwani, President and Chief Executive Officer at ANI. “We believe our new Phase 4 study will provide valuable insights for patients and healthcare providers and further strengthen the profile of Cortrophin Gel in this indication.”

About the Cortrophin Gel Phase 4 Gout Trial

The Phase 4 trial is a randomized, single-center, double-blind, single administration study to evaluate the efficacy and safety of Cortrophin Gel at two dose levels (40 USP units/0.5 mL and 80 USP units/mL) administered as a single injection in patients with acute gout flares for whom non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine did not previously provide an adequate response, among other criteria. The trial will randomize up to 160 patients in a 1:1 ratio between the two doses with the objective of enrolling 70 evaluable patients per dose group for the primary endpoint assessment.

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Cortrophin Gel will be administered as a single dose, followed by a 7-day follow-up period with patient reported assessments conducted at days 1, 2, 3 and 7 post-administration. The primary endpoint of the study is the change in gout pain intensity from baseline in the target joint following Cortrophin Gel administration measured by Visual Analog Scale (VAS) at day 3 post-administration. Secondary endpoints include change in gout pain intensity at days 1, 2 and 7 post-administration, time to onset of effect, time to response, use of rescue medication, patient and physician assessments of response, and safety parameters. Exploratory endpoints include evaluating the effect of Cortrophin Gel on inflammatory biomarkers, health-related quality-of-life measures and health-care resource utilization.

Indication

Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for:

  • Short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis

Important Safety Information

Contraindications

  • Cortrophin Gel is contraindicated for intravenous administration.
  • Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources.

Warnings and Precautions

  • Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections.
  • Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation.
  • Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium.
  • Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of disease.
  • Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated.
  • Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.
  • Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
  • Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response.
  • Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis.
  • Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease.
  • Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.
  • Growth and development: Carefully observe growth and development of infants and children on prolonged corticotropin therapy.
  • Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.
  • Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia.
  • Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adverse Reactions

Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; injection site reactions; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; suppression of growth in children; and weight gain. These are not all the adverse reactions reported with Cortrophin Gel.

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Source – GlobeNewswire