KUALA LUMPUR, Marinus Pharmaceuticals Inc, a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, has initiated the Marinus Access Program, a global managed access programme for ZTALMY (ganaxolone) oral suspension CV.
The new programme 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.
According to a statement, the Marinus Access Program will be managed by Durbin, a leader in the international distribution of specialised pharmaceuticals.
Marinus Chairman and Chief Executive Officer, Scott Braunstein said consistent with the company mission, it is committing appropriate resources to help facilitate broader access to ZTALMY for patients with critical unmet medical needs.
“With the launch of the Marinus Access Program and commercial collaboration agreements in place in 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,” he said.
The United States Food and Drug Administration and European Commission approvals of ZTALMY in CDD are supported by data from the Phase Three Marigold double-blind placebo-controlled trial.
In the Marigold open label extension study, patients treated with ZTALMY for at least 12 months experienced a median 49.6 per cent reduction in major motor seizure frequency.
In the clinical development programme, ZTALMY demonstrated efficacy, safety and tolerability with the most common adverse reactions in the ZTALMY group being somnolence, pyrexia, salivary hypersecretion and seasonal allergy.
Source: BERNAMA News Agency