FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CHMP Recommends Marketing Authorization for Buprenorphine Pump

April 30, 2019
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The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended a marketing authorization for a buprenorphine pump to help manage addicts’ withdrawal from opioids.

The Sixmo implant, owned by Italian firm L. Molteni & C. dei Fratelli Alitti Societa di Esercizio, secretes low levels of buprenorphine from a patient’s upper arm for around six months. It consists of four rods implanted using local anesthesia and it’s designed for addicts who would ordinarily take low doses of a buprenorphine lozenge.

The CHMP recommendation comes after L. Molteni handed up results from three pivotal trials involving some 626 adult addicts. More than 96 percent of patients in the Sixmo group responded to the pump, compared to about 88 percent of patients in the lozenge group.

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