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Marinus Pharmaceuticals Announces U.S. Commercial Launch Of ZTALMY For Seizures Associated With CDKL5 Deficiency Disorder

Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the U.S. commercial launch of ZTALMY®

Benzinga · 07/28/2022 07:40

Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the U.S. commercial launch of ZTALMY® (ganaxolone) oral suspension, CV for the treatment of seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older1.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220722005348/en/

Product image (Photo: Marinus Pharmaceuticals)

“ZTALMY represents an important first for both Marinus and the CDD community and we are proud to make it available for patients by physician prescription,” said Christy Shafer, Chief Commercial Officer of Marinus. “With our highly experienced commercial team, designated specialty pharmacy and comprehensive patient support program, we are well-prepared to bring ZTALMY to market. We look forward to engaging with healthcare providers and supporting patient access to ZTALMY as we raise awareness about CDD and this important new treatment option.”

Physicians can now discuss the availability of ZTALMY as a treatment option with their patients and can access important information at ZTALMYhcp.com about prescribing ZTALMY and the prescription fulfillment process through Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies.

As part of Marinus’ commitment to helping people who are prescribed ZTALMY receive the support they need, the Company has established ZTALMY One™, a comprehensive patient support program that facilitates access to treatment and provides ongoing prescription drug support and education throughout the treatment journey. This includes prescription benefit and prior authorization support, medication delivery, financial support programs for patients with no insurance, limited insurance or a gap in coverage and a co-pay savings program that helps commercially insured eligible patients pay as low as $0 per fill for a ZTALMY prescription. Visit ZTALMY.com to learn about full program offer and terms and conditions. The ZTALMY One support team is available Monday through Friday, 8:00 a.m. to 8:00 p.m. Eastern Time, with pharmacists available 24/7.

ZTALMY was approved by the U.S. Food and Drug Administration in March 2022 based on data from the Phase 3 Marigold double-blind placebo-controlled trial of 101 patients with CDD, published in The Lancet Neurology2, in which ZTALMY significantly reduced the frequency of monthly major motor seizures by a median of 30.7% compared with 6.9% for placebo (p=0.0036). In this trial, 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.

To learn more about ZTALMY and ZTALMY One, please visit ZTALMY.com.