Feb 6 (Reuters) - Shire Plc’s Vyvanse, a top-selling medicine for hyperactivity, failed in two late-stage clinical trials to successfully treat adults with major depressive disorders, the pharmaceutical group said late on Thursday.
The amphetamine-based drug, prescribed to U.S. students to control ADHD, did not perform sufficiently better than a placebo as an add-on therapy for adults who had inadequately responded to two common types of anti-depressants, the company said.
London-listed Shire said based on the results of the two clinical trials, it would no longer pursue the clinical development program for major depressive disorders.
“We estimate Shire’s shares will be down 2 to 3 percent when trading resumes tomorrow,” Leerink analyst Jason Gerberry said, adding that the failed study had come on the heels of mixed clinical trial results for Shire’s dry eye drug lifitegrast.
The brokerage maintained its “outperform” rating on the stock but said its estimates were under review.
“While this news in major depressive disorder is disappointing for patients and Shire, we will later in the year be filing with the FDA for a new indication for Vyvanse in Binge Eating Disorder in adults, and Vyvanse is an effective and leading treatment for ADHD,” Shire Chief Executive Officer Flemming Ornskov said in a statement.
Britain’s third-biggest drugmaker had said in November that the drug was predicted to achieve sales of $1.2 billion this year for ADHD.