Purpose & Structure of GSP
evidence-based scientific statements that outlines the strategic core themes of zuranolone as a treatment for MDD and PPD; serves as a framework to ensure consistent and strategically guided internal and external communications; provides key scientific messages so that Biogen and Sage communicate with one voice on scientific topics across functions.
what is the purpose of the GSP
product profile, MOA, clinical development program, clinical safety, and clinical efficacy
what are the zuranolone pillars
burden of illness/unmet need, mechanism of disease, clinical and economic value
what are the MDD and/or PPD pillars
a category that defines the focus of communication, (eg, MOD, MOA, Efficacy, Safety, Value). Each is paired with a Statement, which describes overall strategic communication focus of that Theme
what is a pillar
Zuranolone is an oral, once-daily, 14-day treatment course in clinical development for adult patients with MDD or PPD.
what is the zuranolone product profile
Administered as an oral 14-day treatment course for episodes of depression, zuranolone has demonstrated rapid onset with sustained clinical outcomes in clinical studies and has the potential to be a cost-effective option that improves health-related quality of life and healthcare resource utilization
clinical and economic value for zuranolone in MDD and PPD
define clear, coordinated communication points that are aligned with each Theme; essentially, they are scientific messages
what are the Key Scientific Statements (KSS)
Zuranolone, an oral positive allosteric modulator (PAM) of both synaptic and extrasynaptic GABAA receptors, is thought to upregulate GABAA receptor expression and enhance inhibitory GABAergic signaling. As a neuroactive steroid, zuranolone is hypothesized to rapidly restore network balance in brain areas dysregulated in depression.
what is the zuranolone MOA
MDD is a heterogeneous disorder that may result from brain network dysregulation, including dysfunctional GABAergic signaling, that is characterized by depressed mood or loss of interest or pleasure in activities and that causes changes in functioning.
what is the MDD mechanism of disease (MOD)
provide the granular level of detail to support each KSS with the best associated reference and key visuals if appropriate
what are evidence statements
Zuranolone is being evaluated as an oral 14-day treatment course in MDD and PPD, and is being investigated as monotherapy, adjunct therapy, or co-initiation therapy with an ADT.
what is the zuranolone clinical development program
Postpartum depression is underrecognized and undertreated despite its prevalence and can have a negative effect on maternal health, child development and family wellbeing. There is an unmet need for rapid acting treatment options for patients with PPD.
what is the PPD burden of illness/unmet need
provides guidance on vocabulary for clear and consistent scientific communications externally – preferred terminology, and terminology that should be avoided
what is lexicon
Zuranolone treatment was generally well tolerated during the 14-day treatment course across clinical studies in patients with MDD and patients with PPD, without withdrawal or persistent side effects observed to date.
With an oral 14-day zuranolone treatment course, rapid improvements in depressive symptoms were observed as early as Day 3 in clinical studies, with effects sustained beyond the treatment period, in patients with MDD and patients with PPD.
What is the clinical safety and efficacy of zuranolone
PPD is a serious medical illness consisting of depressive symptoms which may start during or after pregnancy. The pathophysiology of PPD is multifactorial and may result from brain network dysregulation, including dysfunctional GABAergic signaling and altered regulation of stress response pathways, in addition to contributing factors such as fluctuations in allopregnanolone levels.
what is the PPD mechanism of disease (MOD)