Reckitt Benckiser plans to pull its heroin replacement tablets in the U.S., thanks to new data showing that the Suboxone pills were more likely to be swallowed accidentally by children than other formulations were. In making this voluntary sacrifice, the company puts its alternative Suboxone product--a film version that dissolves on the tongue--in line for increased sales.
FDA didn't order the withdrawal; Reckitt says it made the decision based on an analysis by the U.S. Poison Control Center. The study found that "accidental unsupervised pediatric exposure" to Suboxone was 8 times more likely with tablets than with the film product, which is delivered in individually wrapped doses.
Reckitt says the film version is "child resistant" partly because of that packaging. The film formulation has already garnered more than 60% of the U.S. market for Suboxone, Reuters notes. The pills will be discontinued within 6 months, the company said.
The company's tablet formulation went off patent in fall 2009, while the film version is still patent-protected. Reckitt has predicted that generic rivals for its Suboxone pills would quickly drain away sales; the drug accounts for most of the company's pharma division sales. A Reckitt spokesman told The Guardian, however, that the film's exclusivity rights weren't a factor in the decision to stop making the tablets.