Individual Compassionate Use Policy for the United States and Canada
At ACADIA Pharmaceuticals Inc. (ACADIA), we are passionate about improving the lives of patients with central nervous system disorders. ACADIA is committed to bringing safe and effective treatments to patients by conducting rigorous clinical trials and obtaining regulatory approval for marketing by regulatory agencies. Before new treatments can be made publically available, the United States (U.S.) Food and Drug Administration (FDA) and other regulatory agencies around the world require that investigational medicine(s) are studied in clinical trials.
Clinical trials are the most appropriate way for patients to access investigational medicines being developed by ACADIA. In these trials, the safety and efficacy of investigational medicines is rigorously assessed by ACADIA and the appropriate regulatory agencies in order to understand the medicine’s benefits, risks, and appropriate use, including whether or not it should be approved as an appropriate therapy for the patients’ medical or mental condition. Obtaining regulatory approval is the only way to bring access of a medicine to the greatest number of patients who may benefit from
To learn more about clinical trials that are underway at ACADIA, please visit www.clinicaltrials.gov and search by company name, disease, or investigational medicine.
We understand that there may be some individual patients who do not qualify to participate in an ongoing ACADIA clinical trial, but have serious or life-threatening conditions and have exhausted all available medical options. For these individual patients, when it is allowed by applicable law and meets ACADIA’s Individual Compassionate Use criteria, ACADIA may provide physician requested and managed access to investigational medicine through an Expanded Access Program in the U.S. or through a Special Access Programme in Canada, collectively referred herein as “Individual Compassionate Use”.
Criteria for Considering Requests for Individual Compassionate Use
On a case by case basis, ACADIA considers requests from U.S. and Canadian licensed physicians for access to the investigational medicine for patients who have serious or life-threatening diseases or conditions for which there is no comparable or satisfactory alternative therapy. Specifically, these patients include:
- In the U.S., patients who have a diagnosis of hallucinations and/or delusions associated with dementia; or patients who have schizophrenia symptoms that have not adequately responded to a single antipsychotic medication.
- In Canada, patients who have a diagnosis of hallucinations and/or delusions associated with Parkinson’s disease psychosis.
There are a number of factors that ACADIA may consider upon receiving and evaluating a request for Individual Compassionate Use. These factors include:
- The patient seeking treatment has a serious or life threatening disease or condition, and no alternative therapies to treat the disease or condition are available.
- The physician believes the potential benefits of the investigational medicine will outweigh any potential risks to the patient, as described in the United States Prescribing Information (USPI).
- The physician provides sufficient data to make an assessment of the benefit and risk of the proposed use of the investigational medicine for the patient’s serious or life-threatening disease or condition.
- All necessary regulatory/institutional approvals have been obtained to allow administration of the investigational medicine.
- The patient is ineligible to participate in a clinical trial or there is no such ongoing clinical trial for this serious or life-threatening disease or condition.
- All other important criteria established by the medical experts at ACADIA.
ACADIA does not guarantee access to investigational medicine for a particular patient. Any access to investigational medicine for Individual Compassionate Use is subject to local/national laws and regulations and must also comply with any applicable country-specific laws and regulations, including drug importation and distribution requirements. Approvals from applicable regulatory agencies and by an Institutional Review Board or Ethics Committee from the treating institution must be obtained prior to each Individual Compassionate Use. If approved, the patient (or his/her legal guardian/caregiver) must provide written confirmation of informed consent and both the patient and his/her treating physician must agree to comply with ACADIA’s safety and monitoring and reporting requirements prior to receiving access to the investigational medicine for Individual Compassionate Use.
How do I submit a Request for Individual Compassionate Use?
- Patients in the U.S. and Canada who are interested in requesting Individual Compassionate Use should speak with their physician.
- On the patient’s behalf, a qualified and licensed treating physician may submit a request for Individual Compassionate Use using the link below:
- A treating physician may request additional information or ask questions about ACADIA’s Individual Compassionate Use by contacting ACADIA Medical Information at firstname.lastname@example.org or at (844)-4-ACADIA (844-422-2342).
How are requests evaluated? How long does it take to receive a response?
- ACADIA is committed to prompt evaluation of requests in a fair and unbiased manner.
- Upon receipt of a request, the request will be referred to ACADIA’s Individual Compassionate Use team for evaluation.
- ACADIA typically will acknowledge receipt of a request within five business days.
- The regulatory agency in the country of request (e.g., the FDA in the U.S., Health Canada in Canada) must also approve the proposed use of the investigational medicine.
How can I learn more about the Regulatory framework for Individual Compassionate Use?
- To learn more about the FDA’s regulatory framework for expanded access, including access for Individual Compassionate Use, click here.
- To learn more about Health Canada’s regulatory framework for expanded access, including access for Individual Compassionate Use, click here.
- In general, the FDA strives to respond quickly (within a business day or two), and Health Canada makes every effort to process requests within 24 hours of receipt.
Individual Compassionate Use Request Form