Expanded Access Program (EAP) policy

Relmada Therapeutics’ development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational product, REL-1017 (esmethadone hydrochloride), and to obtain regulatory approval. Relmada is committed to making REL-1017 available to seriously ill patients who in the opinion of their treating physician could potentially benefit from REL-1017.

Major Depressive Disorder (MDD)—Relmada is offering expanded access for REL-1017 to patients with serious and/or life-threatening conditions who are not adequately treated with available therapies and are also not eligible for clinical trials with REL-1017. This EAP is currently only being offered in the United States.

A treating physician, who is able to comply with the requirements that are stated in this policy, may request information about how to apply for access to Relmada’s investigational products by contacting the Company.

Purpose

The purpose of this policy is to describe the requirements for Expanded Access to Relmada investigational product REL-1017 to patients outside of a clinical study.

Scope

This policy applies to provision of access to a Relmada investigational product REL-1017 that is not approved for any purpose in any country, including the United States. This includes the period between regulatory approval of this investigational product and its commercial availability in any country.

Policy statements

Any use of a Relmada investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Relmada policies and procedures.

In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Relmada when it becomes commercially available via the local healthcare system.

A. Patient eligibility criteria

To be eligible for access to an investigational product, patients must meet the following criteria:

Suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from REL-1017 as determined by the treating physician.
Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
Are ineligible or unable to participate in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
Have a disease for which in the opinion of the treating physician there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc.
Not have any pertinent medical condition that would unfavorably alter the projected benefits, as established by the Relmada clinically or medically responsible individual.

B. Investigational product criteria

In addition to the patient eligibility requirements, the investigational product must meet the following criteria:

The product is under investigation in one or more clinical studies.
There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient.
The provision of the investigational product will not interfere with or compromise the clinical development of the product.

C. Treating physician criteria and responsibilities

The physician(s) attending to the patient(s) who is/are receiving an investigational product through expanded access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:

Any applicable country-specific legal and regulatory requirements related to providing esmethadone hydrochloride (REL-1017), an investigational product, under Expanded Access. REL-1017 is currently a Schedule II controlled substance in the United States and is also internationally controlled in Schedule I of the Single Convention on Narcotic Drugs, 1961.
Any Relmada requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.

Contact information