ROMEG Therapeutics Announces FDA Approval of GLOPERBA, the First Oral Liquid Colchicine for Acute Gout Treatment and Improved Drug Interaction Management

VCBeat has learned that GLOPERBA, an oral colchicine solution developed by pharmaceutical company ROMEG Therapeutics, has recently received approval from the U.S. Food and Drug Administration (FDA). This marks the first FDA-approved oral colchicine solution for the treatment of acute gout.

Acute gout is a common and complex form of arthritis caused by excessive uric acid production or impaired uric acid excretion. At night, patients with acute gout often experience sudden onset of severe pain, edema, and redness and swelling in the affected joints. The most commonly affected site is the big toe, with patients describing the sensation during a gout flare as akin to the big toe being on fire.

In the United States, approximately 8.7 million people are affected by acute gout. Colchicine is a commonly used medication for treating acute gout, and the current U.S. market for colchicine is valued at approximately $800 million. Colchicine inhibits the accumulation of leukocytes at sites of inflammation, thereby reducing their phagocytic activity against uric acid, alleviating the inflammatory response associated with acute gout, and achieving rapid pain relief.

However, colchicine can cause visceral side effects. Physicians treating acute gout with colchicine often need to adjust dosages or interrupt therapy to manage drug interactions with other treatments, such as renal dialysis. Determining how to adjust colchicine dosing to meet the needs of gout patients with renal and hepatic impairment is an urgent clinical challenge. ROMEG Therapeutics has addressed this issue with GLOPERBA, an oral solution that allows physicians to easily titrate patient doses compared to existing colchicine capsules on the market. Additionally, approximately 15% of elderly patients in the United States suffer from dysphagia and cannot swallow solid pills; GLOPERBA oral solution enables them to take their medication with ease.

Naomi Vishnupad, Chief Scientific Officer at ROMEG Therapeutics, stated, “GLOPERBA oral solution enables physicians to titrate colchicine dosing for the management of patients with renal and hepatic impairment, representing a significant advancement.” It is understood that GLOPERBA oral solution will be launched in the summer of 2019, at which time it will be available at pharmacies, nursing facilities, and hospitals across the United States.

ROMEG Therapeutics is a pharmaceutical company based in Massachusetts, USA. The company focuses on developing innovative plant-derived medicines to provide better treatment options for physicians and patients.

(Compiled by Jiao Yanli)