Titan Pharmaceuticals has announced the results of a six-month safety re-treatment study (PRO-811) of probuphine in patients with opioid dependence.
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In the open-label study, Probuphine was shown to be well tolerated, including the implant insertion and removal procedures, with a low incidence of adverse events and overall safety profile.
Patients also reported a decreased use of illicit opioids, good control of opioid withdrawal and cravings and high overall satisfaction with Probuphine, the company said.
Titan plans to submit the NDA for Probuphine in the third quarter of 2012.
Titan chief development officer Katherine Beebe said the additional safety results continue to support the potential of Probuphine as a new treatment option for patients suffering from opioid dependence.
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