Over the past three years, liquid formulations of a few older medicines were approved for children, but these have come with a price — a steep price. Although youngsters must no longer struggle to swallow tablets or run the risk of compounded liquid versions, the cost of these new preparations greatly outstrips both generic tablets and the compounded alternatives, according to a letter published today in the New England Journal of Medicine.
The authors noted that the US Food and Drug Administration approvals are the result of a valiant effort — encouraging greater development of pediatric medicines. But as they see it, the facts on the ground turn out to be just another variation on an increasingly common theme: companies finding ways to revamp older medicines and thwarting competition after gaining the imprimatur of the FDA.
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Ed, there is another aspect to the pediatric liquid formulation story. Starting almost 20 years ago there was a big push by the American Pediatric Association to remove the alcohol that was present in many pediatric liquid formulations. Alcohol was great because it extended shelf life, but it also made many of these products taste pretty bad.
Back in the early 2000’s my company partnered with Lilly to develop a pediatric oral solution of nizatidine for pediatric GERD that contained no alcohol. As part of the pediatric exclusivity initiative we developed a pleasant tasting, alcohol-free, bubble gum flavored version of nizatidine for pediatric GERD that the kids, and the parents of those kids loved. The product was approved in 2002, and currently a one month supply sells at a cash price of $412, or about $13 dollars/day. That’s without insurance. Most parents I know would not complain about such a price in return for symptom relief for their child and a good night’s sleep for them.
Hi Pharmvet,
Thanks for the perspective. I do recall that and agree that such improvements are worthwhile, although cost might still be an issue, at least for those without insurance or higher deductibles. In this instance, the GERD medicine may or may not be taken regularly or indefinitely, while a blood pressure medicine for children likely would be, yes? Or am I missing something?
Regards
ed at pharmalot