Medicines Co. : FDA Approves Raplixa To Help Control Bleeding During Surgery

(RTTNews) - Medicines Co. (MDCO) announced that the U.S. Food and Drug Administration has approved RAPLIXA (fibrin sealant) and the RaplixaSpray device to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.

According to IMS data, it is estimated that every year, approximately 2.6 - 3 million surgical procedures require the use of a topical hemostat product in the U.S.

RAPLIXA requires no thawing, reconstitution, or mixing and can be applied either directly from the vial or with the RaplixaSpray device. The device is a low-pressure spray applicator designed to deliver RAPLIXA to larger bleeding surfaces in difficult to reach areas.

RAPLIXA is a fibrin sealant comprised of human-plasma derived fibrinogen and thrombin that is indicated to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.

Separately, The Medicines Company announced that the U.S. Food and Drug Administration has approved IONSYS (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.

IONSYS offers patients recovering from surgery in the hospital control over their analgesic dosing by pushing a button to dispense fentanyl transdermally via an imperceptible electrical current as needed for pain. IONSYS will only be administered to patients in hospitals enrolled in the IONSYS Risk Evaluation Mitigation Strategy (REMS) program and is not intended for home use. The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed.

The Medicines Company expects IONSYS to be available in the U.S. in third-quarter of 2015.