LONDON (Reuters) - Pharmaceutical group Shire PLC said Vyvanse, its amphetamine-based drug prescribed to U.S. students to control ADHD, had also been successful in treating the newly-recognized binge eating disorder (BED) in a trial.
Shares in the London-listed firm rose to an all-time high on Tuesday after it said the drug was superior to a placebo in reducing the number of binge-eating days per week in two randomized late-stage trials.
It said it would submit an application to the U.S. drugs regulator, the FDA, for the approval of the drug for BED after the results of the tests, which were completed earlier than expected.
Shire’s chief executive Flemming Ornskov, who joined the company earlier this year, said he was extremely pleased with the results.
“BED is a condition for which there is no currently approved pharmacologic treatment and yet there is significant unmet patient need, as was demonstrated with the faster than expected enrollment of participants in our clinical trial program,” he said.
Shire said it would present the efficacy and safety data from both studies at a major scientific meeting next year, and it expected to file for FDA approval by the third quarter of 2014.
BED, which was officially recognized as a psychiatric disorder in the United States in May, affects 2.8 percent of U.S. adults in their lifetimes, Shire said, and it is characterized by recurring episodes of binge eating, feeling out of control while bingeing, and feeling guilt and shame afterwards.
Share in Shire hit a high of 2,892 pence in early trade on Tuesday. They were up 1.5 percent at 2,863 pence at 0931 GMT.
Analysts at Deutsche Bank said: “Success in BED studies represent further positive news for Shire, on the back of recent strong Q3 results, but the market opportunity in BED will likely be hard to gauge for some time.”
They said Shire would have to develop the market, pointing to research that said half of the 3 million U.S. adults with the disorder were undiagnosed, and only 7 percent were diagnosed and treated.
Sales well in excess of $500 million a year could be achievable in theory, they said, but they were projecting BED specific sales of $220 million in 2017.
In contrast, the drug was predicted to achieve sales of $1.2 billion this year for ADHD, they added.
Editing by Jane Merriman