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FDA will conduct fast-track review of injectable buprenorphine

November 10, 2015
by Gary A. Enos, Editor
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The existing list of formulation options for the drug buprenorphone to treat opioid dependence could soon grow longer, with last week's announcement of fast-track regulatory review for weekly and monthly injectable versions of the drug.

The partnering companies Braeburn Pharmaceuticals and Camurus, a Swedish company, stated that the Food and Drug Administration (FDA) has granted fast-track designation for the companies' CAM2038 subcutaneous injection products. The companies stated that the weekly and monthly injections have been evaluated so far in 176 patients and healthy volunteers, demonstrating promising drug release and safety.

“By eliminating the need for daily dosing, CAM2038 has the potential to improve medication adherence and help patients avoid relapse, a critical aspect of a comprehensive approach to treating opioid addiction,” said Camurus president and CEO Fredrik Tiberg.

Numerous formulations of the partial agonist have emerged since the buprenorphine-naloxone tablets sold under the brand name Suboxone were discontinued three years ago. Versions currently in use include a film, a sublingual pill, and a formulation that sticks to the patient's cheek.

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