Radium-223 Chloride (Alpharadin) is now available for the treatment of men with advanced prostate cancer who have symptomatic bone metastases (painful) and who are also castration-resistant (hormone-refractory). This is an expanded access program that will allow the use of Alpharadin prior to the formal FDA approval of the treatment.

From the Clinical Trials Web Page :
“Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).

For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations enable manufacturers of such drugs to provide those pat