FDA Approves Abstral for Breakthrough Pain for Patients with Cancer FDA REMS Enrollment Required

REMS programs are required by the FDA for certain marketed drugs to ensure the benefits of a product offered to consumers outweigh the risks.

They can include elements to ensure safe use, communications plans and medication guides, which all require assessment. Just a few months ago, another REMS approval of note was the another drug that could prove to be addictive and I though it was kind of strange as the company for an addictive drug promoted a 7 day voucher on the web and as you can see from the link below it was pain medication for cancer patients.

FDA Approves Risk Education and Awareness For Drugs Used to Promote “Awakeness”–Sleep Apnea & Work Shift Disorder Treatments

The pain reliever has already been approved for the UK and Germany in Europe. BD

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside the cheek, gum, tongue), or the nasal passages or throat where they dissolve and are absorbed.

Abstral is indicated for the management of breakthrough pain in patients with cancers, aged ≥18 years, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, and overdose. Under this program, pharmacies, distributors, and healthcare professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense, and distribute this product.