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December 23, 2013
07:04 EDTTTNPTitan says working to develop Probuphine clinical study design
Titan Pharmaceuticals announced the receipt of the official minutes from a Type C meeting with the FDA on November 19 to discuss the Complete Response Letter to its New Drug Application for Probuphine, an investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients. Per the Minutes, Titan said the FDA emphasized its commitment to working with Titan and its partner, Braeburn Pharmaceuticals, to pursue a reasonable path to approval, and all parties agreed that seeking an indication in individuals stabilized on 8 mg/day or less of sublingual buprenorphine may be a suitable approval pathway for Probuphine. Titan and Braeburn proposed the revised indication following a review of the FDA's comments on the briefing material and to address one of the primary concerns in the CRL regarding dose adequacy among the original study population. The FDA maintained the need for clinical data in this patient population as a requirement for approval, stipulating that the study "need not be large," "be adequate and well-controlled," and "must support labeling for the duration of treatment (6 months)." Titan said it and Braeburn are working with experts in the field to develop a clinical study design for submission to the FDA within the next few weeks.
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