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 Circ...
Scilex Holding Company (SCLX)
Company Research
Source: GlobeNewswire
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 dose adjustment.For patients with severe renal impairment, the starting dose should be 0.3 mg/day.For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week. 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. According to data gathered by Evaluate Pharma, the gout treatment market is projected to reach $2.0 billion in the United
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SCLX
News
- Scilex Holding (NASDAQ: SCLX) had its price target lowered by analysts at HC Wainwright from $12.00 to $8.00. They now have a "buy" rating on the stock.MarketBeat
- Scilex Holding Company Announces Closing of $15 Million Registered Direct OfferingGlobeNewswire
- Scilex Holding Company Announces $15 Million Registered Direct OfferingGlobeNewswire
- Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results For Gross and Net Sales for ZTlido® for the First Quarter 2024; Implements Planned 2024 Commercial Ramp for Additional Opioid Sparing Product and Reduction of R&D and Other AdGlobeNewswire
- Scilex Holding Company Announces Launching of Co-Pay Programs for Both ZTlido® and ELYXYB® for Commercially Insured Patients and the addition of ELYXYB® to a Multi-State Medicaid Pharmaceutical Purchasing Group to Its Purchasing PoolGlobeNewswire
SCLX
Earnings
- 11/14/23 - Miss
SCLX
Sec Filings
- 4/25/24 - Form SC
- 4/25/24 - Form 424B3
- 4/25/24 - Form 424B3
- SCLX's page on the SEC website