Physician Views: With Biogen on board, we ask PCPs/psychiatrists to assess the potential of Sage's zuranolone

Biogen's CNS-focused R&D pipeline (including particular interest in Alzheimer's disease) makes it no stranger to a high-risk/high-reward growth strategy. In the past week it has doubled down on this approach by announcing a collaboration with Sage Therapeutics to co-develop and co-market the experimental drug zuranolone for depression; a disease area where the path to market for novel therapies is notoriously challenging.

Sage experienced this first hand last year when its initial Phase III study of zuranolone for major depressive disorder (MDD) missed its primary endpoint. Having picked through the data, however, Biogen is confident that ongoing studies evaluating a higher dose of zuranolone will work. If results are positive, it could become a novel and disruptive treatment option, partly because of the way it is being utilised in clinical studies.

One pivotal-stage study is evaluating zuranolone as a fast-acting therapy for MDD that can be initially administered for a two-week period followed by 'as needed' short-course retreatments. Another trial is studying its potential use as a rapid response therapy for MDD when co-initiated with new standard antidepressant therapy.

It also holds potential as an oral treatment for postpartum depression (PDD), an indication where Sage markets the drug Zulresso, but uptake has been limited due to the requirement of intravenous administration over a 60-hour period.

To get a better understanding of how zuranolone could impact the treatment landscape if Phase III studies are successful, we are fielding a short survey to primary care practitioners and psychiatrists based in the US and key European markets (France, Germany, Italy, Spain and the UK). The questions we are asking are listed below, including one about the potential importance of new therapies for essential tremor (Biogen will also co-develop SAGE-324 in this indication).

___________

Q. Are you aware of the novel, investigational drug zuranolone, which is being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD)? And if so, what expectations do you have for zuranolone?

Not aware

Aware – no expectation

Aware – low expectation

Aware – moderate expectation

Aware – high expectation

___________

Q. The next few questions relate to the potential role of zuranolone if proven to be effective and approved by regulators.

How would you best describe the potential clinical significance of an effective, fast-acting therapy for MDD, which is initially administered for a two-week period followed by 'as needed' short-course retreatments – up to a maximum of five times?

1 – None             2            3            4 – Moderate    5            6            7 – Very high 

___________

Q. How would you best describe the potential clinical significance of an effective, acute rapid response therapy for MDD when co-initiated with new standard antidepressant therapy?

1 – None             2            3            4 – Moderate    5            6            7 – Very high 

___________

Q. How would you best describe the potential clinical significance of an effective oral therapy for PPD?

1 – None             2            3            4 – Moderate    5            6            7 – Very high 

___________

Q. How would you describe the level of unmet clinical need for an effective therapy to treat essential tremor?

1 – None             2            3            4 – Moderate    5            6            7 – Very high 

___________

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here

 

 

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