Vistagen is passionate about developing transformative treatment options to improve the lives of individuals who are underserved by the current standard of care across multiple highly prevalent indications. We aim to advance our investigational products through the clinical development process efficiently, prioritizing studies that generate data needed for regulatory approval. We are privileged to collaborate with clinical investigators and patients who participate in our studies to further these aims.

However, we recognize that some patients will not be eligible for Vistagen-sponsored clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. However, at this time, to further our goal of bringing these potential therapies to patients as effectively as possible, Vistagen does not currently provide any of its product candidates via expanded access (also referred to as compassionate use). We have considered many factors in arriving at this determination, including our ability to maintain supply for clinical trials, from enrollment to completion.

If Vistagen considers offering expanded access use for any of its investigational product candidates in the future, a request for expanded access would need to be initiated by a licensed physician or healthcare provider (HCP) and include sufficient supporting detail to enable Vistagen to evaluate the request against all relevant criteria under the law and as set forth in any updated policy. For example, if, in the future, Vistagen were to offer expanded access to its investigational products, the criteria it may consider could include the following:
 

• The severity of the patient’s condition;
• Any available alternative treatments or clinical trials;
• The then-current stage of clinical development of the investigational drug and whether the data generated at the time of the request are sufficient to support expanded access at the dose requested and for the particular patient’s condition (i.e., a benefit/risk assessment in light of available data);
• The impact of making the investigational drug available on the continued conduct of clinical trials (e.g., the potential for a negative impact on supply or delay in clinical development), FDA regulatory review, or potential approval of the investigational drug;
• Additional criteria regarding the investigational product, its development program, the patient, or other circumstances that may, in Vistagen’s sole discretion, impact eligibility.

Even if Vistagen updates its policy to consider providing expanded access to its investigational drugs, such policy change would in no way guarantee access to any investigational product by any individual patient, physician, or HCP, as any such request would be evaluated in accordance with criteria established by Vistagen and granted or denied in Vistagen’s discretion (and in each case subject to compliance with all regulatory requirements). Moreover, even if Vistagen were to amend its policy to consider expanded access and were to grant expanded access to any particular patient, it would reserve the right to discontinue the provision of the investigational product to that patient at any time, in each case, subject to all regulatory requirements.
 

If Vistagen, in the future, modifies its policy to consider granting expanded access requests on a case-by-case basis, it would update this policy to provide more detail on the process and timing for acknowledging and responding to such requests. In the meantime, Vistagen expects to deny any such requests and will promptly inform any requesters of their receipt and this decision to deny such requests upon receipt, and in any event within 14 business days of receipt.

More information about Vistagen’s clinical trials is available at www.clinicaltrials.gov, including current trials of fasedienol https://clinicaltrials.gov/study/NCT06358651?intr=PH94B%20Nasal%20Spray&rank=6#more-information.

If you have any questions about our expanded access policy, please contact medinfo@vistagen.com.