Braeburn Pharma re-submits NDA to FDA for Probuphine (buprenorphine HCl) subdermal implant to treat opioid addiction
Titan Pharmaceuticals announced the re-submission by Braeburn Pharmaceuticals of a New Drug Application (NDA) to the FDA for Probuphine, Titan’s subdermal implant containing buprenorphine HCl for the maintenance treatment of opioid addiction. Probuphine is designed to deliver continuous, non-fluctuating levels of buprenorphine for six months following a single treatment.
Comment: Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple FDA-approved drug products for the treatment of opioid addiction, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.
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