Titan Pharmaceuticals, the California manufacturer of a product designed to release a steady stream of buprenorphine over a period of six months, yesterday released what they called positive results of a study of this product in yesterday’s Journal of the American Medical Association.
There’s lots of stuff that none of the journalists have reported about this study.
Beginning with the funding. The JAMA piece said Titan Pharmaceuticals funded this study. What it didn’t say was that last year Titan was awarded $7.6 million in federal funds from the National Institutes on Drug Abuse to study this product over three years. So a big chunk of federal money was awarded to a private pharma corporation.
Also: Titan and the UCLA study authors are calling the implants a success, but more than two-thirds of the implant participants received supplementary Suboxone tablets. That’s like saying, We gave them extra heroin to curb the cravings, but hey! the implants still worked. People do not understand: buprenorphine is an opioid, no matter what formula it comes in, no matter whether you call it an “implant” or a “medication” or a “drug.”
The product, which Titan has named Probuphine, is a 26-mm rod impregnated with the opioid buprenorpine. It’s designed to be surgically placed underneath the skin on the non-dominant arm. (Women have long used technology like this with contraceptive hormone implants.) Over time it keeps drug levels at a steady state in the bloodstream.
Titan’s people are calling this steady-state release one of the big advantages of Probuphine—no fluctuations in drug-plasma levels, the way there are with pills like Suboxone, or liquids like methadone.
They may have a point here. Suboxone has a 37-hour half-life. Let me explain how half-life works: When the drug is orally dosed every 24 hours, many physicians believe, Suboxone stacks up in the bloodstream—the body does not metabolize it faster than it’s dosed. But if it can be released in a steady trickle dose, then it might not stack up.
Titan and NIDA are also saying that because the drug is implanted, it’s impossible to divert. This is the big selling-point for the rods. Patients can’t hawk it on the black market, the way they do with Suboxone or other drugs. Code for this: they say it “improves patient compliance,” which means patients simply have no choice other than to take the drug, because it’s stuck inside the body.
How the study worked
The study involved a group of patients that received four Probuphine rods, and another group that received placebo rods. Both groups could also receive Suboxone pills if they were experiencing withdrawal or craving (up to 12 or 13mg per day!—an equivalent of about 525mg morphine. I mean, why even give your patients implants if you’re going to let them take an extra 12mg of Suboxone?) in the first 16 weeks of the study; for the last eight weeks, participants who elected to get an extra implant were limited in the amount of extra Suboxone they could receive. And everyone had to go to “counseling.”
Results of the study that everybody’s reporting (source: JAMA—I wish I could provide a link to the entire study, but the link above only gives you the abstract):
RESULTS NOBODY’S REPORTING:
Especially if “counseling” was the only other solution offered to them.