Last month, popular addiction field blogger and North Carolina internist Jana Burson, M.D., posted about a novel idea — to taper from Suboxone, cut the film in smaller pieces. This is presuming that patients are using the film, not the tablets, but it is a “great way to taper,” she wrote, cautioning that counseling should take place first and that her patients who tapered were on the medication for two years first.

Burson, who was praised by Gil Kerlikowske, director of the Office of National Drug Control Policy (ONDCP) for her treatment of opioid addiction, acknowledged that the manufacturer does not recommend cutting the film because there’s no proof of how much medication is in anything but the entire strip. The labeling approved by the Food and Drug Administration (FDA) is silent about cutting the film.

We asked the Substance Abuse and Mental Health Services Administration (SAMHSA) to comment. Nicholas Reuter, senior public health analyst with SAMHSA’s Center for Substance Abuse Treatment, said this “amounted to bio-equivalency questions that would probably be best addressed by the FDA.”

So we asked the FDA about this methodology for tapering. Press officer Chris Kelly responded that the FDA “does not have information on the effects of cutting the films into smaller pieces.” He added, however, that “this may be considered a practice of medicine issue, and FDA does not regulate the practice of medicine.”

In other words, the FDA does not interfere in doctors’ clinical decisions, many of which involve off-label use of medications.

Pharmaceutical companies also are not allowed to promote the off-label use of their medications, but we asked Tim Baxter, M.D., global medical director for Suboxone manufacturer Reckitt Benckiser, about the practice of cutting the film in order to taper off the medication.

“Cutting the film is not something that we are able to recommend,” Baxter told ADAW. “There’s been no stability testing data to show that the film is suitable for something like that,” he said. Does that mean that the film would not be stable if cut? Baxter says no, but the company has “done no testing to say it is stable” if cut.

Taper or not?

What, then, would Reckitt Benckiser recommend for patients who do want to taper? “We’re not able to make a recommendation specifically on tapering because FDA does not include such a protocol in our labeling,” said Baxter. “However, we can point you to research done in some other countries with other labels,” he said, citing an experiment done by Walter Ling, M.D., but cautioning that “there is no consensus on the right way to do this.”

There are two protocols: one is a very gradual reduction over weeks or months, and the other is a rapid taper, said Baxter. There is some controversy over whether the rapid taper is actually more comfortable — fewer days of withdrawal symptoms — than the slow taper. What is clear, however, from the study published in the Archives of General Psychiatry last fall (see ADAW, November 14, 2011), is that 9 out of 10 people who taper off Suboxone — who are on Suboxone for a short period only — will relapse. In that study, which was funded by the National Institute on Drug Abuse Clinical Trials Network, the treatment was a taper lasting only a few weeks.

“My personal feeling is that this is something that should only be undertaken once the prescriber and the patient believe the time is right,” said Baxter, who said that if patients must taper, they should do it very slowly, in his opinion. “Opioid dependence is a chronic disease,” he said. If patients do taper, there has to be a “relapse plan,” he said. There is no protocol in the United States for coming off Suboxone.

But in some cases, patients have no option: the payer puts a cap on treatment duration, so financial, not clinical, considerations determine whether the patient decides to taper.

This concerns Baxter, who doesn’t think payers would put a time limit on diabetes medication. “You may not need to be on the medication forever, but you do need to treat the disease,” he said. “Not every patient is the same.”

New film dosages

Last month, the FDA approved two line extensions to the Suboxone film product line that make it possible to increase the dose by 2- and 4-milligram increments with just one film. The company does not discuss the possibility of using the new doses to taper. The new doses are 4 and 12 milligrams. The previously approved dosages are 2 and 8 milligrams. 

Last year, we reported that Reckitt Benckiser investor communications stressed the importance of transferring patients from tablet to film, due to possible generic competition for the tablet; the film is protected by patent (see ADAW, May 11). However, Reckitt Benckiser says that it developed the film “in response to the needs and preferences of physicians and patients,” and also to reduce pediatric exposure, which, the company said, is made difficult by the unit-dose packaging of the film.

Meanwhile, in a subsequent post, Burson betrayed her personal bias about treatment: that as a physician, she is in favor of treatment without medication, if that is possible, citing as an example using diet and exercise instead of medication to treat diabetes.