FDA approves highly concentrated liquid morphine for severe pain

In good news for cancer patients at the end of life,  the Food and Drug Administration has approved a concentrated liquid morphine to relieve acute and chronic pain in patients where other opiates are no longer working.

Although concentrated doses of liquid morphine have used to manage pain for opiate-tolerant patients for some time, the oral concentrated dose was not FDA approved.

The FDA has worked with Roxane Laboratories, the only manufacturer of the 20mg/mL formulation, to be sure that adequate supplies are available to patients in need. 

The action is part of the FDA unapproved drugs initiative.

As part of the unapproved drugs initiative, the FDA had previously sent warning letters to companies that manufactured and distributed  concentrated liquid morphine. After hospice programs and others who help patients at the end of life expressed serious concerns about not having the liquid morphine for cancer patients who could no longer swallow pills, FDA put the ban on hold until the medicines could get approval.

In announcing the approval, Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research said,

An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards. Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.