Marinus Pharmaceuticals Announces Resumption of Phase 3 RAISE Trial in Status Epilepticus
Excerpt from the Press Release:
RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has resumed screening and recruitment for the Phase 3 RAISE (Randomized Therapy in Status Epilepticus) trial in refractory status epilepticus (RSE). The company continues to expect topline RAISE trial results in the second half of 2023.
Marinus announced in February that it was pausing recruitment in the RAISE trial after routine stability monitoring showed visible particulates of aluminum phosphate in the drug solution. During the pause, the chair of the independent Data Monitoring Committee for the trial reviewed the clinical safety data and determined no concerning safety events were identified in patients already treated with the batches of IV ganaxolone.
The trial has resumed utilizing new batches of the current IV formulation. Marinus has implemented a reduced shelf life of 12 months. In agreement with the U.S. Food and Drug Administration, ganaxolone clinical supplies will be stored under refrigerated conditions for the entire duration of clinical use. Marinus anticipates modifying the IV ganaxolone formulation with a new buffer by end of the third quarter of 2022, targeting a shelf life of at least 24 months.
The company continues to expand the number of participating clinical trial sites for the RAISE trial in the U.S. and Canada and is working closely with key investigators and site coordinators to support enrollment efficiencies with more than 50 sites now activated.
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