An opioid drug for cancer pain has been made available in the U.S. through a controlled distribution program called FOCUS, for Full Ongoing Commitment to User Safety. FOCUS is an FDA-mandated Risk Evaluation and Management Strategy (REMS) program.
The FDA recently issued its first guidance for industry on REMS, which the regulator can require in cases where it wants to make sure that a drug's benefits outweigh its risks.
The drug is Onsolis, which was launched in the U.S. this week by Meda Pharmaceuticals for breakthrough pain in adult cancer patients already receiving opioid therapy. The drug is administered as a small dissolvable polymer film that the patient applies to the inner lining of the cheek.
Under FOCUS, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive Onsolis. The program provides educational materials, patient counseling and managed distribution.
- here's the announcement
- see our FDA REMS coverage