The FDA has given its blessing to an expedited development route for Sage Therapeutics’ depression pill SAGE-217, upgrading its ongoing study to a pivotal trial.
The move – which ties in with FDA Commissioner Scott Gottlieb’s stated ambition to getting drugs approved more quickly – means that Sage will be able to file a marketing application on the strength of the phase II trial, rather than waiting for the end of a phase III programme. That’s been an option for cancer drugs for a while, but this is thought to be the first time a truncated pathway has been used for an antidepressant.
SAGE-217 is being tested in post-partum depression (PPD) that affects mother after childbirth as well as major depressive disorder (MDD), for which Sage reported positive phase 2 results last December, and already has breakthrough designation from the FDA.
Based on meetings with the agency, the company thinks it should be able to file for approval in PPD based on the results of the phase II study – assuming the final results due later this year are positive – and a single, placebo-controlled phase III trial in MDD that is scheduled to start in the second half of 2018.
SAGE-217 is billed as a next generation GABAA positive allosteric modulator that offers once-daily oral dosing and is a follow-up to Sage’s lead antidepressant brexanolone, which is delivered intravenously and is being studied for the acute treatment of severe PDD. Brexanolone has also shown efficacy in phase II testing and has the potential to be the first drug ever approved and launched in the US specifically for PPD – potentially as soon as the first half of next year.
The excitement behind the drugs is that they seem to show a clinical effect quickly, within just days of starting treatment, according to Sage’s chief executive Jeff Jonas. In contrast, current antidepressants can take weeks or months to start working and often come with significant side effects
“We are exploring the potential for patients with MDD to feel well within days, with just a two-week course of treatment – similar to how antibiotics are used today – instead of enduring long-term chronic treatment,” he said.
“SAGE-217, if successfully developed and approved, may rewrite the textbook on how the tens of millions of people suffering from MDD are treated, ultimately turning depression into a disorder, not an identity,” added Jonas.