Data from a phase 3 randomized, placebo-controlled clinical trial of Probuphine have been published in the Journal of the American Medical Association ( JAMA ). The article highlights data from the 163-patient trial, which showed that patients receiving Probuphine implant had significantly less illicit opioid use, experienced fewer symptoms of withdrawal and craving, stayed in treatment longer and had greater overall improvement when compared to placebo patients over the course of the 24-week study.

Probuphine is an innovative, subcutaneous implant formulation designed using Titan's proprietary ProNeura technology to deliver a steady, round-the-clock low dose of the marketed drug Buprenorphine over six months following a single treatment.

According to Walter Ling, at the David Geffen School of Medicine at UCLA, the introduction of Buprenorphine into clinical practice is arguably the most significant improvement in the treatment of opioid addiction in the last decade; however, physicians excited with the clinical success of buprenorphine are also rightfully concerned about medication adherence and diversion ( and potential for abuse ) of the sublingual formulations of Buprenorphine. Probuphine does away with these concerns by eliminating the need for take home doses. Additionally, by providing a sustained blood level of active medication, Probuphine helps diminish the daily fluctuation of the medication effects ( and potentially side effects ) and reduces the total exposure of Buprenorphine over time.

Patients receiving Probuphine had a mean percentage of urine samples that tested negative for illicit opioids across the full 24 weeks of 36.6%; those in the placebo group had a mean of 22.4% ( p=0.01 ).
Nearly 66% of patients receiving Probuphine completed the study versus the 31% who received placebo implants ( p<0.001 ).

Probuphine patients experienced fewer clinician-rated ( p<0.001 ) and patient-rated ( p=0.004 ) withdrawal symptoms; moreover Probuphine patients reported lower ratings of craving ( p<0.001 ).
Probuphine patients had a greater change on clinician global ratings of severity of opioid dependence ( p<0.001) and demonstrated a greater change on the clinician global ratings of improvement ( p<0.001 ).
Minor implant site reactions were the most common adverse events and were consistent across the Probuphine and placebo groups,

The World Health Organization ( WHO ) estimates that 2.8 million individuals in the U.S. and Europe are addicted to illicit opiates such as heroin, and more than 2.0 million individuals in the U.S. alone are addicted to prescription opioid medications. It is estimated that about 20% of this population are currently receiving pharmacological treatment.

Source: Titan Pharmaceuticals, 2010

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