August 16, 2011 — Treatment with an investigative buprenorphine implant (Probuphine, Titan Pharmaceuticals, Inc) significantly reduces opioid dependence and may be similarly effective to daily buprenorphine-naloxone oral therapy, new data suggest.
The novel subcutaneous formulation delivers a steady, around-the-clock dose over a 6-month period and is intended to decrease the risk for opioid diversion and abuse while ensuring therapeutic adherence and potentially improving medical outcomes.
In the phase 3 randomized study conducted by the company at 20 sites in the United States, 287 patients aged 18 to 60 years were randomly assigned to receive the buprenorphine implant (n = 114), 12 to 16 mg of sublingual buprenorphine with naloxone per day (Suboxone, Reckitt Benckiser Pharmaceuticals, Inc; n = 119), or placebo implants (n = 54) for up to 24 weeks.
Results showed that use of the buprenorphine implant significantly decreased opioid use relative to placebo (mean percentage of urine samples negative for illicit opioids, 36% vs 14%; P < .0001) and improved clinician-rated measures, such as global severity and global improvement in opioid dependence (P = .0003 and .0002).
Further analyses revealed device efficacy to be noninferior to sublingual buprenorphine-naloxone in all measures, including negative urine results (36% vs 35%), clinician-rated global severity (P = .7831), and clinician-rated global improvement (P = .9881).
The findings confirm prior data released by the company in July 2011 and will be presented on September 8, 2011, at the 13th annual meeting of the International Society of Addiction Medicine in Oslo, Norway.
"In my opinion, [the buprenorphine implant] combines the right medication with the right delivery system. We all know that people with opioid addiction may have difficulty taking effective medications reliably," said Richard N. Rosenthal, MD, in a company news release.
"These Phase 3 trial results confirm that this medication strategy has specific promise in our national battle against opioid dependence, in that it is both efficacious and reduces the potential risk to patients from missed doses and to the public through intentional or unintentional diversion."
Dr. Rosenthal is chairman of psychiatry at St. Luke's-Roosevelt Hospital Center, a teaching hospital of Columbia University in New York City, and past president of the American Academy of Addiction Psychiatry.
Treatment-emergent adverse events reported in the study were mild to moderate and most commonly included headache (13.2% vs 16% for buprenorphine-naloxone and 9.3% for placebo), upper respiratory tract infection (8.8% vs 9.2% and 7.4%), depression (8.8% vs 2.5% and 3.7%), insomnia (7.9% vs 13.4% and 14.8%), sore throat (7.0% vs 3.4% and 1.9%), nausea (6.1% vs 6.7% and 1.9%), and vomiting (6.1% vs 4.2% and 1.9%).
Buprenorphine previously was approved alone and in combination with naloxone as once-daily sublingual formulations (Subutex and Suboxone, Reckitt Benckiser Pharmaceuticals, Inc) for the maintenance treatment of opioid dependence.
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