We recognize that some patients may seek access to unapproved treatments outside of a clinical trial through the U.S. Food and Drug Administration's (FDA) Expanded Access (EA) program.

Our policy

Levomecor does not submit Expanded Access INDs directly to FDA.

• If a treating physician believes a patient may benefit from esmethadone, Levomecor will consider providing the investigational drug to the physician.

• The treating physician is responsible for submitting the Expanded Access request to FDA as a Physician's IND (commonly via FDA Form З926 for single-patient INDs).

Levomecor's role

If Expanded Access is deemed appropriate, Levomecor will:

• Provide the investigational drug, subject to supply availability.

• Supply the treating physician with necessary information (safety, dosing, CMC data).

• Authorize FDA to reference Levomecor's IND for supporting information.

The treating physician will be responsible for:

Submitting the EA IND request to FDA.

• Securing Institutional Review Board (IRB) approval/notification.

• Overseeing patient care and monitoring.

• Meeting FDA safety reporting obligations.

How to Request Expanded Access

Licensed U.S. physicians may submit requests to Levomecor at: administration@levomecor.com

Please include:

• Physician's name, specialty, and contact details.

• Patient's condition and medical rationale for the request.

• Proposed treatment plan.

Levomecor will acknowledge receipt of requests within 5 business days.

Important notice

Posting this policy does not guarantee that Expanded Access will be granted. Expanded Access may only be considered if:

• Clinical trial participation is not possible, and

• Providing investigational product will not interfere with ongoing or planned clinical development.

For information on esmethadone trials, please refer to ClinicalTrials.gov.