Surgical Implantation, Dosage Issues Raise FDA Flags Over Titan’s Anti-Opioid Drug

FDA reviewers appear satisfied with Titan Pharmaceuticals’ Probuphine’s overall safety, but worry surgically implanting the anti-opioid drug may cause adverse events similar to those that plagued Wyeth’s discontinued contraceptive Norplant. FDA reviewers also question whether adequate dose exploration has been conducted.
Drug Industry Daily