FDA OKs The Medicines Company’s Opioid Pain Patch, Spray-On Sealant

The Medicines Company expects its Ionsys opioid pain patch to be available in the third quarter of this year, following FDA approval last week.

Ionsys’ (fentanyl iontophoretic transdermal system) approval was one of the two for the drugmaker that day. The FDA also approved the firm’s Raplixa, a spray-dried fibrin sealant used to control bleeding during surgery.

The first-of-its-kind pain-control patch delivers fentanyl through patients’ skin using a small electric current at the touch of a button, without requiring any kind of needle or programming adjustments.

Raplixa, a biological product, is indicated for adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when standard techniques such as suture, ligature and cautery are ineffective or impractical, according to the firm’s ProFibrix subsidiary.

The approval was based on a Phase 3 clinical study involving about 720 patients over 11 months, which showed the time needed to stop bleeding with Raplixa is superior to using a sponge alone. — Lena Freund and Jonathon Shacat