FDA clears Ionsys and Raplixa from The Medicines Company

|About: The Medicines Company (MDCO)|By:, SA News Editor

The FDA approves The Medicines Company's (NASDAQ:MDCO) Ionsys (fentanyl iontophoretic transdermal system) for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital. Ionsys is a needle-free, patient-controlled, pre-programmed fentanyl delivery system, a credit card-sized self-adherent device. The drug is delivered via an imperceptible electric current on an "as-needed" basis. According to a recent survey, patients experience moderate-to-severe pain in ~65% of the 51M in-patient surgeries in the U.S. each year.

The company acquired the rights to Ionsys when it acquired Incline Therapeutics in 2012. Incline acquired the rights to the device from Alza in 2010.

The FDA also clears Raplixa (fibrin sealant) and the RaplixaSpray device to provide adjunctive hemostasis for mild-to-moderate bleeding in adult patients undergoing surgery when control of bleeding using standard techniques (e.g., suture, ligature, cautery) is ineffective or impractical. RaplixaSpray is a low-pressure spray applicator that delivers Raplixa to larger bleeding surfaces in difficult-to-reach areas. According to IMS, there are as many as 3M surgical procedures each year in the U.S. that require a hemostat product.

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