Innovation Pharmaceuticals Inc (IPIX)

[mdphd2008]

From the American Cancer Society website:

Compassionate Drug Use

What is compassionate drug use?

Medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available.

Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs. These drugs are generally available only to people who are taking part in a clinical trial (a research study that is testing the drug).

Being able to use one of these drugs when you are not in a clinical trial is most commonly referred to as compassionate use.

Single patient access

Patients who don’t qualify for either clinical trials or an expanded access program (if one exists) may be able to get the unapproved new drug by applying for single patient access.

In this case, the patient’s doctor must first ask the drug company if the drug can be used for the patient and see if the drug company will supply it. If the company agrees, the doctor works with the drug company to ask the FDA to approve the drug for use by this one patient.