Shire says its attention-deficit hyperactivity disorder drug Vyvanse has impressed in late-stage trials as a potential treatment for binge eating disorder in adults.
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 late-stage trials.
The Ireland-headquartered group has announced top-line results from two Phase III studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine) versus placebo in adults with BED. In both, the Shire drug was found to be statistically superior at weeks 11 to 12 in terms of number of binge days per week and safety was consistent with the known profile established in studies in adults with ADHD.
Shire noted that because of faster-than-expected completion of both studies, it will now submit an application to the US Food and Drug Administration for the BED indication by third-quarter 2014. Chief executive Flemming Ornskov said “we are extremely pleased with these results”, noting that BED is a condition for which there is no currently approved pharmacologic treatment.
However, he added that “there is significant unmet patient need, as was demonstrated with the faster-than-expected enrollment of participants in our clinical trial programme”. BED was only formally recognised as a distinct psychiatric disorder in May in the USA where it is estimated to affect 2.8% of adults at some stage in their lives.
Susan McElroy of the University of Cincinnati claimed that the disorder “is an important public health problem that is under-recognised, and causes great distress for patients”. She added that increased awareness of BED “among the medical community is greatly needed, as are novel treatment strategies for individuals suffering from this often secretive disorder”.
Approval in the BED indication will boost Shire’s already-impressive sales for Vyvanse. Third-quarter revenues for the ADHD drug climbed 21% to $299.2 million.
