DrugNewsWire

There is a new type of drug being released by a company called Biodelivery Sciences. According to Biz Journals, U.S. drug regulators are on the verge of approving a drug called Onsolis.

The approval is taking a long time because there are more trials to-do with the drug than expected. The FDA has sent the company a letter promising that it will be approved once tweaks are made to the application for approval. The drug, which will be very helpful to the mitigating the pain suffered by cancer patients.

The drug waiting approval is called Onsolis and it is a painkiller for cancer sufferers. It is a patch that is attached o the inside of the mouth and then releases a painkiller called fentanyl.

This is a very powerful painkiller and it is used to treat what is called break through pin in cancer victims. Sometimes this is also noted as pain that is experienced on top of the chronic pain felt by many people who are stricken with cancer.

During the FDA review there were no problems found with the drug itself. Instead the drug company was asked to create a new risk management plan for the drug . This is because the application that Biodelivery Sciences created did not meet changes to FDA regulations.

Basically, the U.S. Federal Food and Drug Administration want Biodelivery Sciences to develop what’s known as a Risk Evaluation and Mitigation Strategy. A REMS, as the plan is known for short, is a plan to help employ a drug with a known risk or side effect. The known side effect in this case is the risk of addiction because the drug is opiate based.

Despite snarls of red tape the drug is expected to be fully approved once the company makes amendments to all of the paperwork and submits the Risk Evaluation and Mitigation Strategy. The drug is expected to be related in late 2009.