Compassionate Use

Marinus is dedicated to developing new therapies for patients with rare seizure disorders, and to serving patients, their families and the healthcare professionals who care for them.

Consistent with our mission to bring innovative medicines to patients with serious or life-threatening conditions, we are focused on conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. Clinical trials are an essential part of collecting the necessary data on safety and efficacy to support regulatory approval. At the same time, we understand that there are patients who will not be eligible for our clinical trials and for whom there are limited options for alternative therapies. In these circumstances, Marinus will consider providing a physician with pre-approval access to a Marinus investigational drug for the treatment of an individual patient outside of a clinical trial under certain conditions.

These conditions include the following:

– The patient has a serious or life-threatening illness or condition and has no comparable or satisfactory alternative therapy available;

– The patient is ineligible for enrollment into or unable to access ongoing clinical trials;

– A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;

– The patient meets any other important medical criteria established by the medical experts working on the product development program;

– Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug;

– Adequate supply of the investigational drug is available; and

– Such access is allowed as per local laws and regulations.

We continually evaluate the benefit-risk profile of our investigational drugs based on evolving clinical data and may make changes to this Compassionate Use Policy when appropriate.

Marinus is committed to evaluating all requests in a fair and equitable manner by qualified Marinus experts. All requests must be submitted by the patient’s treating physician. Marinus may require more detailed information to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by the Marinus review team whose decisions are final.

Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to ManagedAccess@marinuspharma.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within three (3) business days after receipt. If this is an urgent medical request, please contact Alex Aimetti aaimetti@marinuspharma.com.