Expanded Access

Expanded access is a potential pathway for a patient with a serious or life-threatening condition to gain access to an investigational drug product outside of a clinical trial when no comparable or satisfactory therapy options are available and clinical trial participation is not an option.

An investigational drug product is an experimental therapy that has not yet received regulatory approval. The safety and efficacy of the product are still being evaluated in clinical trials, the potential risks and benefits for a specified use are not yet established. 

Expanded Access Policy

At Pasithea we are committed to developing safe and effective therapies and making them available to patients as quickly and efficiently as possible.

As part of that commitment, we support expanded access programs when we have substantial scientific evidence to support both the safety and the efficacy of an investigational drug product for an indication, and when it is logistically practicable.

Pasithea has a two-step process for determining whether the company will grant a request to provide an investigational drug product through expanded access. If according to the first step, expanded access to the investigational drug product is appropriate and the investigational drug product should be available as a general matter, then we will evaluate the request according to the second step.

STEP 1.

Pasithea will evaluate whether:

  • There is substantial scientific evidence to support both the safety and the efficacy of the investigational drug product for an indication, typically after positive Phase 3 data are available.
  • It has been established that providing the investigational drug product on an expanded access basis will not interfere with the initiation, conduct or completion of clinical trials or the regulatory pathway to marketing approval.
  • There is intent to gain regulatory marketing approval for the investigational drug product in the region/country of the request.
  • The product is intended to treat a serious or life-threatening disease, and existing approved therapies are not appropriate or effective, such that consideration of using and unapproved therapy is justified.
  • There is an adequate supply of the investigational drug product.
  • The investigational drug product can be administered – and it is logistically feasible to make it available – outside of the clinical trial setting.

STEP 2.

Pasithea will determine whether:

  • The request has been made by a qualified and licensed physician with expertise and facilities appropriate for the administration of the therapy and the capabilities to monitor, manage and report side effects, as well as to assess patient experience.
  • The patient to be treated has a serious or life-threatening disease, and existing approved therapies are not appropriate or effective, such that consideration of using an unapproved therapy is justified.
  • The patient does not qualify for participation in ongoing or pending clinical trials.
  • The patient’s condition is of a type and stage commensurate with the indication for which the investigational drug product is likely to be approved.
  • The patient’s underlying medical conditions do not pose safety risks that have not been sufficiently studied.
  • All required regulatory agency approvals and institutional approvals have been obtained to allow administration of the investigational drug product.

Expanded Access Request and Response

Requests for access to investigational drug products must be made by a properly licensed and medically qualified physician on behalf of the patient. Requests are considered by qualified and licensed physicians at Pasithea on a case-by-case basis in a fair and equitable manner based on the program information available at the time of the request and the eligibility criteria listed above.

Qualified physicians can submit a request to Pasithea at: ExpandedAccess@pasithea.com with the following information:

  • date of request
  • requesting physician’s name, contact information, address (including country), and professional designation (i.e., MD) or qualifications
  • name of the requested investigational drug product and physician’s intended treatment plan, including therapeutic indication and expected duration of treatment
  • medical rationale for the request, including an explanation for why alternative therapy cannot be used, why the patient does not qualify for a clinical trial, and why use of the investigational drug product is in the patient’s best interest.

Pasithea anticipates it will acknowledge receipt of a request within five business days of receipt of the request.

Additional information regarding our pipeline of investigational drug products can be found on our Pipeline page here.

Information specific to Pasithea clinical trials can be found at www.clinicaltrials.gov.

This policy is in accordance with Section 561A(f)(2) of the Food, Drug, and Cosmetic Act (§21 U.S.C 360bbb-0 – Expanded Access Policy Required for Investigational Drugs). Pursuant to this Act the posting of policies by manufacturers and distributors shall not serve as a guarantee of access to any specific investigational drug by any individual patient.