BioCentury
ARTICLE | Company News

FDA reviewers question Probuphine efficacy, safety

March 20, 2013 12:28 AM UTC

Titan Pharmaceuticals Inc. (OTCBB:TTNP) fell $0.85 (42%) to $1.19 on Tuesday after FDA reviewers questioned the efficacy and safety of Probuphine buprenorphine to treat opioid dependence. In briefing documents released ahead of Thursday's Psychopharmacologic Drugs Advisory Committee meeting to discus an NDA for Probuphine, the reviewers said that while Probuphine led to more opioid-negative urine samples -- the primary efficacy measure in Phase III trials -- and less supplemental sublingual buprenorphine use compared with placebo, the overall response "was not what one might hope."

Additionally, the reviewers noted that many patients needed supplemental treatment with sublingual buprenorphine during the final months of the six-month treatment period, which suggests that the clinically-tested dose of Probuphine is "not adequate for some patients." The reviewers, who questioned whether further dose exploration of Probuphine should be required prior to approval, were also concerned about the safety of Probuphine and potential complications related to surgical implantation of the product. ...