At Neurim, our mission is to develop medicines that meaningfully improve the lives of people affected by serious conditions. We are committed to advancing innovative therapies for patients with unmet medical needs through rigorous science, thoughtful clinical development, and responsible regulatory pathways.
We believe the best way for patients to access an investigational medicine – one that has not yet received regulatory approval – is through participation in a well-designed, controlled clinical trial. Clinical trials are essential to determine safety and effectiveness and to support regulatory approval so that medicines can become broadly available to patients who need them.
However, in cases where a clinical trial is not an option, and a patient has exhausted all available treatment alternatives, regulators or health authorities may grant permission for a treating physician to request access to an investigational drug prior to approval.
Such individual access to a medicine prior to regulatory approval is commonly referred to as “expanded access”, “compassionate use”, or similar terms depending on regional regulations.
Neurim refers to these requests collectively as Expanded Access (EA).
Eligibility Considerations for Expanded Access
Neurim evaluates Expanded Access requests based on medical, ethical, scientific, and operational criteria. Consistent with FDA regulations (21 CFR 312 Subpart I), the following conditions must be met:
- The patient has an immediately life-threatening disease OR a serious disease associated with morbidity that has substantial impact on day-to-day functioning.
- No comparable or satisfactory alternative therapy exists.
- The patient is not eligible for any ongoing clinical trial involving the investigational product.
- Available clinical and scientific data provide reasonable expectation of potential benefit, and potential benefits outweigh potential risks.
- 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 for broader patient access;
- Sufficient drug supply is available to support the request.
- A regulatory pathway exists in the relevant country or region that permits Expanded Access.
We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis. Approval of Expanded Access is not guaranteed, and Neurim evaluates each request individually.
Special Note Regarding Slenyto® (Melatonin Prolonged-Release)
Slenyto® is an approved and marketed Neurim product in the European Union, UK, Australia, Canada and in other countries outside the United States.
It is not approved or commercially available in the US at this time.
While Slenyto® is an approved product internationally, access in the US can only occur through FDA-regulated mechanisms, including clinical trials or an Expanded Access pathway when appropriate.
Neurim will evaluate physician-initiated Expanded Access requests for Slenyto in the US only under the conditions outlined in this policy, and only where permitted by FDA and local regulatory frameworks.
Ongoing Review and Program Availability
Neurim regularly reviews whether Expanded Access can be responsibly offered for a given investigational or non-US-approved product, especially as new clinical data emerge. This internal review ensures that decisions support patient safety, scientific integrity, and timely development of new therapies.
If Neurim opens an Expanded Access Program (EAP) – for an investigational product or for Slenyto® in the United States – the program details, eligibility criteria, and request procedures will be posted publicly on this website.
If no EAP is listed, Expanded Access is not currently available, and participation in a clinical trial remains the only pathway for access.
Important Considerations
Investigational medicines, and approved medicines that are not yet approved in some regions, may have unknown or evolving safety and efficacy profiles. Patients and physicians should carefully evaluate potential benefits and risks when considering Expanded Access.
We encourage patients to consult directly with their treating physician regarding current or future options, clinical trials, and whether Expanded Access may be appropriate.
Physician Contact Information
For medical inquiries regarding a Neurim investigational medicine or Slenyto® access in the US:
MedInfo@neurim.com
Requests for information will typically be acknowledged within 5 business days.
Certain Neurim products may be developed or co-developed with partners; Expanded Access availability may depend on these agreements.
Policy Updates
In accordance with the 21st Century Cures Act, Neurim may revise this policy at any time.
At this time, Neurim does not have any investigational or unapproved products available through Expanded Access in the United States.
