Expanded Access Policy
At Double Bond Pharmaceutical, we are dedicated to developing innovative first-in-class approaches for the treatment of cancers, infections, and other life-threatening disorders. We work to develop therapies for the broadest group of patients possible by engaging in clinical research with the goal of obtaining regulatory approval of our products to demonstrate that they are safe and effective.
The best way for patients to access medicines prior to approval is through participation in clinical trials. However, in some rare and very specific circumstances where enrolment is not possible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines. This process is referred to under different terms, the most common being compassionate use, expanded access or named patient programs.
Double Bond Pharmaceutical will consider expanded access requests to an investigational medicine outside of a clinical trial on a case-by-case basis for patients with a serious, life-threatening or imminently debilitating condition based on an assessment of the following:
- The patient’s physician determines that there is no comparable or satisfactory therapy available to treat the patient’s condition
- In the opinion of the treating physician, the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition
- There is sufficient evidence of the safety and efficacy of the investigational therapy to support its use in the treatment of the patient’s condition
- The patient (or patient’s legal guardian) and a licensed physician are both willing to participate and complete regulatory requirements
- Providing the investigational therapy will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing material
- The patient meets inclusion criteria for participation based on their clinical status
- The patient is unable to obtain the investigational drug via a clinical trial
Procedure for Submitting a Request
- A licensed physician overseeing the care of a patient must submit a request directly to Double Bond Pharmaceutical
- Double Bond Pharmaceutical will acknowledge receipt via the third-party company facilitating the expanded access program. The company will provide a form for the provision of additional data including at least the following information:
- Demographics of the proposed patient
- Relevant medical history, including all therapies administered to date for the relevant indication
- Assessment of patient’s prognosis
- Rationale for requesting access to the investigational drug
- Double Bond Pharmaceutical will notify requesting physician of initial decision of patient eligibility based on review of information received via the third party
- If approved, further details will be provided to the requesting physician and on-going communication will commence
- There is no appeal process for a request that has been denied
Currently Double Bond Pharmaceutical has an Early Access program in place for Temodex® (Temozolomide gel) for the treatment of glioblastoma brain tumours. To learn more about the Temodex® Early Access program, please visit this page or email Temodex@AlexaviHealthcare.com.