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Sage Therapeutics Announces The Lancet Publishes Positive Phase 2 Brexanolone (SAGE-547) Clinical Data in Severe Postpartum Depression
- Study showed significant mean reduction in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score compared to placebo -
- Seventy percent of subjects in the study experienced remission of symptoms within 60 hours of treatment with brexanolone and maintained effect until 30-day follow-up -
"There is a significant unmet need for new treatment options in PPD, for
mothers suffering from the disorder, as well as their children
and families. Currently available pharmacologic treatment options for
PPD do not target the underlying mechanism or biology," said
"Postpartum depression is a common, biological complication of
childbirth. It is a serious mood disorder associated with a range of
debilitating symptoms that impact a women's ability to function, and is
a leading cause of maternal suicide," said
The study's primary efficacy endpoint was the mean change from baseline in the 17-item HAM-D total score in subjects who received brexanolone compared with subjects who received placebo at the 60-hour time point. As previously reported, at the end of the 60-hour infusion, brexanolone-treated subjects demonstrated a mean reduction in HAM-D total score of 20.97 points, a 12.2-point difference [95 %CI, -3.67 to -20.77] from placebo (p=0.008). The effect was statistically significant from 24 hours after initiation of treatment (-19.37 vs -8.12, p=0.006) until the 30-day follow-up (-20.77 vs -8.84, p=0.010). No deaths, serious adverse events or discontinuations were observed. Overall, fewer patients who received brexanolone experienced adverse events compared with placebo (4 of 10 on brexanolone and 8 of 11 on placebo). The most commonly reported adverse events in the trial were dizziness (2 brexanolone-treated subjects; 3 placebo-treated subjects) and somnolence (2 brexanolone-treated subjects; 0 placebo-treated subjects) and an equal number of patients reported the cluster of dizziness, sedation or somnolence (3 in brexanolone group and 3 in the placebo group).
PPD-202A Study Design and Additional Highlights
The paper,
titled "Brexanolone
(SAGE-547 injection) in post-partum depression: a randomized controlled
trial," reports findings from a double-blind, randomized,
placebo-controlled, Phase 2 registration study of brexanolone in 21
women with severe PPD (10 in the brexanolone group and 11 in the placebo
group). At baseline, the mean HAM-D scores for both groups was greater
than 28. Subjects were randomized 1:1 to receive either a single,
continuous intravenous (IV) infusion of brexanolone or placebo for 60
hours.
Prespecified secondary endpoints of the study were assessed using
validated and clinically relevant rating and diagnostic scales to
evaluate severity of depression and to serve as a guide to evaluate
recovery from baseline at 2 hours through 30 days. The outcomes were
consistent with the primary endpoint results and included significant
findings in measures assessed with the HAM-D, CGI (Clinical Global
Impression Scale), and MADRS (
About Postpartum Depression
Postpartum depression (PPD) is a
distinct and readily identified major depressive disorder that is a
biological complication of childbirth, affecting a subset of women
typically commencing in the third trimester of pregnancy or within four
weeks after giving birth. PPD may have devastating consequences for a
woman and for her family, which may include significant functional
impairment, depressed mood and/or loss of interest in her newborn, and
associated symptoms of depression such as loss of appetite, difficulty
sleeping, motor challenges, lack of concentration, loss of energy and
poor self-esteem. Suicide is the leading cause of maternal death
following childbirth. It is estimated that PPD affects 500,000 to
750,000 mothers in the US each year.1,2 There are no approved
therapies for PPD and there is a high unmet medical need for improved
pharmacological therapy in PPD.
About the Hamilton Rating Scale for Depression (HAM-D)
HAM-D
is a validated rating scale used to provide an assessment of depression,
and as a guide to evaluate recovery. This scale is an accepted
regulatory endpoint for depression. The scale is used to rate the
severity of a patient's depression by probing mood, feelings of guilt,
suicide ideation, insomnia, agitation, anxiety, weight loss, and somatic
symptoms.
About Brexanolone (SAGE-547)
Brexanolone is an allosteric
modulator of both synaptic and extrasynaptic GABAA receptors.
Brexanolone has been granted Breakthrough Therapy designation by
the U.S. Food and Drug Administration (FDA) and PRIority MEdicines
(PRIME) designation from the
Brexanolone is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE) in the global Phase 3 STATUS Trial. For more information about the STATUS Trial, please visit www.statustrial.com. Brexanolone has been granted both Fast Track and orphan drug designations by the FDA for the treatment of SRSE.
About
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation: our
expectations regarding the potential for brexanolone in the treatment of
PPD; our view as to the unmet need for additional treatment options in
PPD and how brexanolone might address the needs of PPD patients and
families, if successfully developed and approved; our estimate as to the
number of patients with PPD; and our plans and expectations with respect
to development of brexanolone and our other product candidates. These
forward-looking statements are neither promises nor guarantees of future
performance, and are subject to a variety of risks and uncertainties,
many of which are beyond our control, which could cause actual results
to differ materially from those contemplated in these forward-looking
statements, including the risks that: we may not be able to successfully
demonstrate the efficacy and safety of brexanolone or any of our other
product candidates at each stage of development; success in early stage
clinical trials may not be repeated or observed in ongoing or future
studies of brexanolone; the efficacy data generated in ongoing or future
clinical trials may be less robust or we may encounter unexpected safety
or tolerability issues; ongoing or future clinical trials may not
support further development of brexanolone or our other product
candidates or be sufficient to gain regulatory approval to market any
product; decisions or actions of regulatory agencies may affect the
initiation, timing, progress, number, size and cost of clinical trials,
and our ability to proceed with further clinical trials of a product
candidate in a particular indication, or at all, or our ability to
obtain marketing approval; we may decide that a development pathway for
a product candidate in one or more indications is no longer feasible or
advisable or that the unmet need no longer exists; the number of
patients with PPD or the unmet need for additional treatment options may
be significantly smaller than we expect; and we may encounter technical
and other unexpected hurdles in the development and manufacture of our
product candidates; as well as those risks more fully discussed in the
section entitled "Risk Factors" in our most recent Quarterly Report on
Form 10-Q, as well as discussions of potential risks, uncertainties, and
other important factors in our subsequent filings with the
1 Hamilton BE, Martin JA, Osterman MJK, et al. Births: Final data for 2014. National Vital Statistics Reports. National Center for Health Statistics, 2015, 64, 12. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_12.pdf.
2 O'Hara MW, McCabe JE. Postpartum depression: Current status and future directions. The Annual Review of Clinical Psychology, 2013, 9, 379-407. doi: 10.1146/annurev-clinpsy-050212-185612.
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