GlaxoSmithKline, the U.K.-based pharmaceutical group, will launch on Wednesday the first weight-control drug to be "switched" from prescription to over-the-counter sales in the U.S., according to the Financial Times.
The newspaper did not name its source, but said Alli will go on sale in pharmacies and other outlets in the U.S. priced at about $55.00 a month, closely linked to an advertising campaign designed to stress that it should only be used in conjunction with weight loss programmes.
The newspaper said this approach reflects an increasing political and consumer backlash in the US towards drugs that are aggressively sold to a large number of patients through extensive direct-to-consumer advertising campaigns.
It also reflects the failure to generate large sales in the U.S. for the heavily marketed drug in its prescription format under the brand name Xenical, leading its developer, Roche of Switzerland, to sell the over-the-counter rights to GSK.
Alli is also shortly to be filed for regulatory approval in Europe, the first drug to switch from prescription use applying the centralised procedures of Emea, the European Union-wide London-based regulatory body.