GSK Receives Complete Response Letter for "Undisclosed" Yucky Drug
GlaxoSmithKline and drug development partner Eurand have received a “complete response letter” from the FDA for a mystery compound — EUR-1048. GSK and Eurand have both declined to reveal what EUR-1048 is for.
Eurand’s statement says:
EUR-1048 is an orally disintegrating tablet (ODT) formulation with an undisclosed active compound co-developed by Eurand and GSK.
In its website for the product, Eurand says only:
EUR-1048 is an orally disintegrating tablet formulation that we are developing for GSK. We are using our Microcaps® taste-masking and AdvaTab® orally disintegrating tablet technologies in developing this product.
An extremely brief Reuters report doesn’t solve the mystery either. But this article on In-Pharma Technologist.com gives a lot of background. Essentially, EUR-1048 is a taste-masking chemical delivery device that turns existing yucky drugs into more palatable ones:
The Microcaps system masks unpleasant tastes or odours by encapsulating each particle of the drug substance in a continuous membrane that forms an inert barrier between the drug and the taste buds.
One assumes, therefore, that the application is for an existing GSK brand that tastes yucky and is worth investing further development monies in. Any guesses, readers? Some companies believe there are significant profits to be made by making Rx drugs palatable, with flavors, the way OTC ones already are.
GSK is not alone in receiving a CRL. As this analysis over at Eye on FDA shows, CRLs are increasing while approvals are decreasing, occasionally crushing the stock prices of companies who get the letters by as much as 62 percent.
Image by Flickr user Salvez Dodd, CC
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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