Reckitt Benckiser official: Commitment to opiate treatment stays strong

The global medical director at Reckitt Benckiser Pharmaceuticals, Inc. says the company will maintain its commitment to furthering medication-assisted treatment for opiate addiction in the U.S., despite its move to discontinue distribution of Suboxone tablets as of March 18.

Sales of sublingual Suboxone film, which already account for an estimated 60% of overall sales of the buprenorphine/naloxone combination in the U.S., will continue, and Reckitt Benckiser’s Tim Baxter, MD, says consumers generally have expressed a preference for sublingual film over sublingual tablets. The film dissolves more quickly than the tablets, offering an advantage in administration.

Baxter also rebutted media reports critical of Reckitt’s filing of a “Citizen’s Petition” with the Food and Drug Administration (FDA) to require stricter packaging standards on all buprenorphine products; the FDA denied the request this month. Critics have said the pharmaceutical company filed the petition to fend off competition as its patent protection on Suboxone was expiring, but Baxter says the move coincided with the availability of data documenting a risk of accidental exposure involving children.

Commenting on the notion that the company’s move was primarily business-driven, Baxter says, “I completely disagree with that interpretation. It’s a purely time-based coincidence as to when the data became available and amenable to analysis.”

Baxter says the company’s research has found that Suboxone film carries an eight times lower risk of pediatric exposure than Suboxone tablets. Yet it has not been able to pinpoint a clear explanation for this discrepancy, and Baxter says that is the primary reason why the FDA decided it could not move to require stricter packaging requirements for buprenorphine products.

As a result of these recent developments, two companies now have received the go-ahead to market generic versions of the buprenorphine/naloxone combination. At the same time, Baxter says Reckitt remains committed to promoting the sublingual film, and access to medication-assisted treatment for opiate addiction in general.

“Medication-assisted treatment is now fairly well-accepted in practice,” says Baxter, with some traditionally non-medication treatment organizations recently embracing its use. “Our success has been due to improving access to treatment.”