RADNOR, PA — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) recently announced the initiation of the Marinus Access Program, a global managed access program for ZTALMY® (ganaxolone) oral suspension CV. The new program enables physicians to request ZTALMY for eligible patients with seizures associated with CDKL5 deficiency disorder (CDD) in geographies where the product is not commercially available and as supported by local regulatory requirements. The Marinus Access Program will be managed by Durbin, a leader in the international distribution of specialized pharmaceuticals.
“Consistent with our company mission, we are committing appropriate resources to help facilitate broader access to ZTALMY for patients with critical unmet medical needs,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “With the launch of the Marinus Access Program and commercial collaboration agreements in place in Europe, China and the MENA region, we are proud to advance our global access strategy and provide pathways to make ZTALMY available for appropriate CDD patients in geographies where there are no approved treatment options and local regulations allow.”
The U.S. Food and Drug Administration and European Commission approvals of ZTALMY in CDD are supported by data from the Phase 3 Marigold double-blind placebo-controlled trial, in which 101 patients were randomized and individuals treated with ZTALMY showed a median 30.7% reduction in 28-day major motor seizure frequency, compared to a median 6.9% reduction for those receiving placebo, achieving the trial’s primary endpoint (p=0.0036). In the Marigold open label extension study, patients treated with ZTALMY for at least 12 months (n=48) experienced a median 49.6% reduction in major motor seizure frequency. In the clinical development program, ZTALMY demonstrated efficacy, safety and tolerability with the most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in the ZTALMY group being somnolence, pyrexia, salivary hypersecretion and seasonal allergy. In May 2022, the results from the Marigold study were published in The Lancet Neurology.1
1 The Lancet Neurology, Volume 21, Issue 5, P417-427, May 01, 2022
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.