Otsuka Pharmaceutical Development & Commercialization, Inc. - Expanded Access

Otsuka Pharmaceutical Development & Commercialization, Inc. (“OPDC”) is committed to maintaining the health and well-being of patients and understands that while it is always preferable for a patient to participate in a clinical trial, it is not always possible.  In those situations, OPDC may be able to provide access to an investigational drug through the Expanded Access program.  Expanded access, also known as compassionate use, is the use of an investigational medical product, one that has not been approved by FDA, outside of the use of a clinical trial.  Otsuka accepts requests for Expanded Access from physicians currently treating patients for whom there are no other treatment options available.  To be eligible for access to an investigational product, the applying physician must certify that the patient for whom the application is being submitted meets the following criteria*:
  • The patient is suffering from a serious or life threatening disease or condition;
  • the patient has undergone appropriate standard treatments without success;
  • there is no comparable or satisfactory alternative treatment available or no standard treatment exists for the disease or condition;
  • the patient is not able to participate in any ongoing clinical study of the drug related to the treatment of the patient’s condition;
  • provision of the drug will not interfere with the development of the product; and
  • the potential benefits to the patient outweigh the potential risks.
Questions, requests for an application form and completed application forms should be submitted to:  ExpandedAccess@otsuka-us.com. Otsuka will confirm receipt of an application within one week and will advise of any additionally required information after the initial review of the application.  Protocols for individual patients will be developed on a case-by-case basis as the requests for access are approved by OPDC.  Information pertaining to any drug for which an Expanded Access Study is developed will be made available, as required, after the protocol is approved.  For general information about publicly and privately supported clinical trials conducted around the world, please visit  https://clinicaltrials.gov. * Note that meeting these criteria does not guarantee access to any investigational product.