FDA Approves Abstral to Stop Misuse

The U.S. FDA has approved the use of Fentanyl (Abstral) tablets for opioid-tolerant cancer patients to help manage initial pains that occur suddenly and require a temporarily higher dose of a patient's usual opioid schedule. The drug keeps “breakthrough” pain under control and bearable for adult cancer patients.

It was approved under the speculation that it would lower the abuse and misuse of the drug, but the FDA isn’t conceding without regulation. Doctors practiced in the use of Schedule II opioids are the only ones able to prescribe the product, and furthermore, any facilities that provide the drug to patients directly will be required to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program, that is meant to lower the chances of misuse and abuse.

Abstral's safety was tested in several clinical studies that involved 311 opioid-tolerant cancer patients who suffered from breakthrough pain. Some common side effects include nausea, constipation, drowsiness and headache. FDA also warned that death, while uncommon, has and may occur, but only due to improper patient selection and improper dosing. They hope that the required class now associated with the drug will help eliminate those issues.