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Marinus Pharmaceuticals initiates Global Access Program for ZTALMY® (ganaxolone) Oral Suspension CV

7 Nov 2023 | By Uniphar Access

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today 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 Uniphar, 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 

About the Marinus Access Program  
The Marinus Access Program enables physicians to request ZTALMY® (ganaxolone) oral suspension CV for eligible patients with seizures associated with CDKL5 deficiency disorder in geographies where the product is not commercially available and as supported by local regulatory requirements. The program does not provide free of charge access to ZTALMY and does not affect patients already taking ZTALMY as part of a clinical trial. The Marinus Access Program is managed by Uniphar, a leader in the international distribution of specialized pharmaceuticals. 

Access requests in geographies where Marinus has a commercial arrangement in place are managed by the local commercial organization and are not eligible for the Marinus Access Program: 

  • European Economic Area, United Kingdom, Switzerland: Orion Corporation 
  • Algeria, Bahrain, Egypt, Iraq, Jordan, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Tunisia, and United Arab Emirates: Biologix FZco 
  • Mainland China, the Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan: Tenacia Biotechnology Co., Ltd. 

Physicians can learn more about the Marinus Access Program for ZTALMY by sending an email to

About Marinus Pharmaceuticals 
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA-approved prescription medication ZTALMY® (ganaxolone) oral suspension CV in the U.S. in 2022 and continues to invest in the potential of ganaxolone in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. For more information about Marinus visit

About ZTALMY® 
ZTALMY (ganaxolone) oral suspension is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain. It is a prescription medicine that has been approved by the U.S. Food and Drug Administration and the European Commission for appropriate patients with CDKL5 deficiency disorder.  

U.S. Prescribing Information for ZTALMY® (ganaxolone) oral suspension CV. 

Full European Summary of Product Characteristics for ZTALMY® (ganaxolone) oral suspension is available at 

Uniphar Access
Uniphar’s access team prides itself on being experts in optimizing access, transforming lives and accelerating product development. We harness the capabilities, infrastructure and experience of Uniphar’s diversified pharmaceutical services, leveraging more than 55 years of building success with 200+ multinational clients.

Our highly experienced team deliver best-in-class access programs with a personal touch and true passion for patient outcomes. We leverage our extensive therapy area experience, local and global launch expertise to deliver pre-approval product access, while providing medical affairs strategies tailored to your market. Our commercial team launch assets, fully commercialize in-licensed therapies and manage established brands using innovative digital and in-person solutions to deliver success.

As part of Uniphar’s Pharma division, access, medical and commercial work together to unlock access to innovative therapies and optimize value while improving patient outcomes around the world.

We provide tailored specialist services and solutions for our clients’ changing needs throughout every stage of the product lifecycle. A publicly traded company with €2b revenue, 3,500 employees and active in more than 160 countries, Uniphar is dedicated to improving patient access to medicines worldwide.

About CDKL5 Deficiency Disorder 
CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder characterized by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment.2 It is caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. The CDKL5 gene produces a protein that is important for normal brain development and function.3 

Company Contacts

Jim DeNike 
Senior Director, Investor Relations 
Marinus Pharmaceuticals, Inc.  

Molly Cameron 
Director, Corporate Communications & Investor Relations 
Marinus Pharmaceuticals, Inc.