Category Archives: Press Release

Scilex Holding Company announces completion of commercial manufacturing of Gloperba® with the brand marketed and distributed under Scilex Pharmaceuticals, Inc. and is expecting to Launch in the U.S. in the first quarter of 2024

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. The gout treatment market is projected …

Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba® Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed

Seek approval from the FDA for the modification of the Gloperba® label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below: Patients with mild or moderate renal or hepatic impairment should be considered for …

Scilex Holding Company announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which will be launched in the US in the week of June 10th 2024

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. The gout treatment market is projected …

Scilex Holding Company Announces FDA Final Approval to Precision Dosing for GLOPERBA® Label

FDA Final Approval to Precision Dosing for GLOPERBA® Label. We believe GLOPERBA® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase …

Scilex Holding Company Amends its License Agreement with Romeg Therapeutics, LLC, For the Worldwide Rights to Commercialize Gloperba®, an FDA-Approved Prophylactic Treatment for Painful Gout Flares in Adults

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Over 70% of gout patients have comorbid conditions that may require dose adjustments, and such patients could be a potential target population for Gloperba®1 Over 17% of gout patients on colchicine …

Romeg Therapeutics Announces Publication of RMG-03 Phase 2 Study Results in COVID-19

WOBURN, Mass., April 4, 2023 /PRNewswire/ — ROMEG Therapeutics, LLC (“Romeg”), an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, today announced the publication of results from its recently completed Phase 2 proof of concept study of RMG-03 in COVID-19 patients. The results from the exploratory study, evaluating the effect …

Romeg Therapeutics Announces Issuance of U.S. Patent for Pilocarpine Oral Solution

WOBURN, Mass., Feb. 1, 2023 /PRNewswire/ — ROMEG Therapeutics, LLC (“Romeg”), an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 11,564,909 (the ‘909 patent) directed to the methods and composition of ROMEG’s proprietary formulation of …

Scilex Holding Company, a Sorrento Company, enters into an agreement for an exclusive license with ROMEG Therapeutics, LLC, for the right to commercialize Gloperba®, an FDA-approved prophylactic treatment for painful gout flares in adults, in the US.

Gloperba is an FDA-approved, oral medication for treating painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 8.7 million people in the United States1. As gout cases increase every year, treatment requirements increase. The gout treatment market is large and projected to be $8.3 billion in the US by 2025 …