Brintellix has failed to beat the placebo in a Phase II trial in adult ADHD patients. Lundbeck (CPH:LUN) and its partner Takeda were looking to the trial to open a new indication for the antidepressant, but the data have dented their hopes.
The partners gave one of two daily doses of the drug, which is now known as Trintellix in the U.S., or a placebo to 227 adults with ADHD. Lundbeck and Takeda were looking for changes in the symptom rating scale AISRS over the course of the 12-week trial. Improved AISRS scores indicate a patient’s impulsivity, hyperactivity and inattention are being brought under control. Brintellix failed to deliver such improvements against placebo in the study.
“[Brintellix] failed to achieve significance in separating from placebo,” Lundbeck wrote in its third quarter results.
Lundbeck has yet to post a detailed breakdown of the data but has found a shred of hope in its analysis to date. More than 30% of patients had extremely low or no exposure to Brintellix. This happened “simply because they did not take the medicine,” a Lundbeck spokesperson said. “It is an adherence problem.”
When these patients were cut from the analysis, Lundbeck saw “a clear signal versus placebo.” The Danish drugmaker sees this as evidence Brintellix could still be effective in ADHD, but as it has only just got the data it is yet to decide on its next steps.
Brintellix has advanced this far in ADHD--and all the way to approval in other indications--despite a lack of understanding of the mechanism of action underpinning its antidepressant effects. Lundbeck thinks it is the only drug that inhibits serotonin and acts as an agonist of 5-HT1A, a partial agonist of 5-HT1B and an antagonist of 5-HT3, 5-HT1D and 5-HT7.
Finding a path forward for Brintellix in ADHD would provide a boost for a drug that has experienced a tricky 2016. FDA went against the recommendation of its advisory committee in March to reject an expansion of the drug’s label. Lundbeck and Takeda were trying to gain clearance to market the drug as a treatment for aspects of cognitive dysfunction seen in patients with major depressive disorder.
The setbacks in cognitive dysfunction and now ADHD have dampened expectations label expansions can quickly power Lundbeck and Takeda toward blockbuster sales. Lundbeck, which discovered the drug, generated sales of DKK 773 million ($115 million) from the product over the first nine months of the year. Takeda gives Lundbeck a share of U.S. and Japanese revenues, plus royalty payments, under the terms of a $385 million pact the companies formed in 2007.