Scilex said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (SNDA) for label updates to Gloperba.
According to the company, Gloperba is the only FDA-approved liquid formulation of colchicine specifically designed for preventing acute gout flares in adults.
The drug offers a precise liquid dosage option that allows healthcare providers to tailor treatment for patients at risk, reducing the risk of severe toxicity.
Gloperba allows effective management at doses below the standard 0.6mg. Scilex said that a 150ml bottle of Gloperba will last over 30 days at lower doses.
Additionally, Gloperba is particularly valuable for patients with severe renal impairment, as it allows for a reduced daily dose of 0.3mg.
In June, Scilex received FDA approval for the commercial manufacturing of Gloperba.
A recent market research study conducted by Scilex among rheumatologists highlighted a significant interest in Gloperba as a liquid colchicine formulation for precision dosing.
Rheumatologists who prescribe colchicine for gout flare prophylaxis in adults expressed a strong preference for gout flares therapy over traditional tablets or capsules.
The study also indicated a preference for at-risk patient populations that require more precise dosing to reduce the risk of colchicine toxicity.
The recommended dosage of Gloperba for adults and adolescents over 16 years old is 0.6 mg once or twice daily. The maximum recommended dose is 1.2mg per day.
Scilex is engaged in acquiring, developing, and commercialising non-opioid pain management solutions for acute and chronic pain.
Its commercial products include ZTlido, which is FDA-approved for relieving neuropathic pain associated with postherpetic neuralgia.
Another product, Elyxyb, is the only FDA-approved oral solution for the acute treatment of migraines, whether with or without aura, in adults.
Scilex is also advancing three product candidates including SP-102, a viscous gel formulation of dexamethasone for epidural injections to treat sciatica. It has completed Phase 3 studies and received fast track status from the FDA.
SP-103 is a next-generation, triple-strength lidocaine formulation designed for chronic neck pain. The asset recently completed Phase 2 trials for low back pain, and it has also received fast track status.
Lastly, SP-104 is a low-dose delayed-release naltrexone capsule being developed for fibromyalgia, with its Phase 1 trials completed in Q2 2022.
Last month, Scilex partnered with China-based ACEA Therapeutics to expand access to ZTlido programme.
