Key considerations for the FDA approval of zuranolone for postpartum depression treatment

Mixed-bag approval hit Sage hard but spared Biogen

Sage Therapeutics recently notched an FDA win for the neuroactive steroid zuranolone (Zurzavae) for postpartum depression (PPD). For major depressive disorder (MDD), however, the agency handed the drug a complete response letter. In the wake of the news, Sage’s stock is down 46% to $19.52, while BIIB, which jointly developed the drug, ticked up slightly to $270.34 over the past five trading days.

Sage’s zuranolone partnership with Biogen may soften the blow, said Emma Wille, healthcare analyst for Citeline. But it’s clear that the MDD failure was “a hit,” she noted. “MDD is a huge market, and a lot of key opinion leaders were very interested in this drug because of its novel mechanism and a short course,” Wille said, referring to its 15-day course of administration.

Zuranolone is now the newest rapid-acting option for a mood disorder

Traditionally, patients newly prescr…

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FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder

Zuranolone molecule image from PubChem

FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness.

The former approval represents a milestone as the first ever FDA-authorized oral medication specifically for PPD, a condition estimated to affect one in five new mothers. 

Still, the rejection for MDD, which affects more than 21 million American adults, sent Sage’s stock valuation reeling. In early afternoon trading, SAGE shares were down 52.24% to $17.24. In contrast, Biogen stock was up 0.47% to $270.19. 

Sage’s optimism for Zurzuvae in PPD treatmentt

In a business update call, CEO Barry Greene attempted to accentuate the positive. “We&#…

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Zuranolone, novel oral medication for depression and postpartum depression, could be on the horizon

[Zuranolone image courtesy of PubChem]

Biogen (Nasdaq:BIIB) and Sage Therapeutics (Nasdaq:SAGE) have announced that the FDA accepted the New Drug Application (NDA) for zuranolone, a neuroactive steroid.

The drug candidate could be a novel 14-day oral medication to treat Major Depressive Disorders (MDD) or postpartum depression (PPD). Priority review has been granted and the application is slated to be processed by August 5, 2023.

LANDSCAPE and NEST programs

In their FDA filing, Biogen and Sage have shared data from the LANDSCAPE and NEST clinical development programs and a Phase 2 study conducted by Shionogi Japan.

The LANDSCAPE program contains five studies on zuranolone for adults with MDD, while the NEST program has two studies investigating the drug for adult women with PPD.

In clinical trials, patients with MDD and PPD showed efficacy with zuranolone in as few as three days. In contrast…

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How zuranolone could change the antidepressant market

[Zuranolone image courtesy of PubChem]

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB) have filed a rolling NDA submission to the FDA for zuranolone, a potentially novel, rapid-acting, daily treatment for adults with major depressive disorder (MDD) and postpartum depression (PPD). 

If approved, zuranolone could significantly alter the antidepressant market. A neuroactive steroid, the drug would be prescribed as a 14-day oral short-term treatment for MDD and PPD. By contrast, many patients taking traditional antidepressants do so for at least six months and often for multiple years. 

Zuranolone could diversify the treatment landscape for depression

In clinical trials, zuranolone demonstrated efficacy in as little as three days in patients with MDD and PPD. Conversely, patients beginning a course of antidepressants must wait multiple weeks to determine whether they are effective.  


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10 emerging antidepressants to keep an eye on

[Zuranolone image courtesy of Wikipedia]

Antidepressants remain some of the most widely prescribed drugs, but most popular antidepressants are now available as generics. While selective serotonin reuptake inhibitors (SSRIs) and SNRIs (serotonin and norepinephrine reuptake inhibitors) remain the most commonly prescribed antidepressants, various new types of drugs may be available in the future. For example, drug companies are working on getting everything from an opioid kappa receptor antagonist to an oral neuroactive steroid on the market for depressive disorders.  

Here, we survey 10 antidepressants that may change the mental health landscape in the coming years.  

1. Esmethadone

The (S)-enantiomer of methadone, esmethadone (dextromethadone; REL-1017) from Relmada Therapeutics (Nasdaq:RLMD) is headed to a Phase 3 study for major depressive disorder (MDD). The drug candidate was efficacious on days 4, 7 a…

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Zuranolone could offer rapid relief from postpartum depression 

Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers.

“Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only made the situation worse.

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB) are optimistic about the prospects of zuranolone, a drug candidate for postpartum depression, that met primary and key secondary endpoints in the Phase 3 SKYLARK study. If approved, the drug would be the first oral therapy for postpartum depression.

The treatment response in the placebo-controlled study was “robust,” Meltzer-Brody said.

Patients two received a 50 mg daily dose of zuranolone, a neuroactive steroid, had a 15.6 reduction in the 17-item Hamilton Rating Scale for Depression (HAM-…

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Sage Therapeutics and Biogen formally pursue FDA approval for zuranolone for depression

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD).

The two companies plan on submitting additional clinical data for the NDA in the second half of the year.

Biogen entered into a $1.5 billion licensing agreement with Sage Therapeutics to commercialize zuranolone (SAGE-217) and SAGE-324 in late 2020.

Zuranolone is an oral neuroactive steroid GABA-A receptor positive allosteric modulator (PAM).

In Phase 3 clinical trials, zuranolone 50 mg is administered daily for 14 days.

In addition to MDD, Sage and Biogen plan on pursuing approval for zuranolone in PPD starting next year.

The drug candidate won Fast Track Designation from the FDA in 2017 in MDD and Breakthrough Therapy Designation a year later.

Data were positive from the LANDSCAPE and NEST clinical trial programs.

“Zuranolone has the p…

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Zuranolone shows promise in treating postpartum depression

Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression.

The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.

After a 15-day treatment period, the zuranolone group had a mean change in HAM-D score of −17.8, resulting in a final mean score of 11.0, which is the normal range. Meanwhile, the −13.6 change in the placebo group results in a final mean score of 14.8, indicating mild-to-moderate depression.

For context, in the HAM-D system, a score of 10–13 indicates mild depression. The range of 14–17 represents mild to moderate depression. A score higher than 17 indicates severe depression.

[Related: Biogen bets $1.5B on Sage Therapeutics’ n…

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Biogen Q1 earnings beat estimates, raises EPS guidance 

Biogen (NASDAQ: BIIB) posted first-quarter results that beat analysts’ consensus forecast. The company raised its earnings guidance, but the outlook for the rest of the year largely hinges on FDA decisions regarding its pipeline drugs aducanumab and zuranolone.

The Cambridge, Mass.-based biotech reported revenue of $2.69 billion for the quarter ended March 31, 2021, which is a decrease of 24% compared with the same quarter in 2020.

Adjusted to exclude one-time items, earnings per share were $5.34 on sales of $2.69 billion. Analysts at Canaccord Genuity were looking for EPS of $5.06 on sales of $2.68 billion. The consensus forecast was also for EPS of $5.06.

[Related: Biogen moves forward with aducanumab launch plans]

“Our first quarter 2021 results were consistent with our expectations across MS, SMA, and biosimilars despite increased competition,” said CEO Michel Vounatsos in a statement.

The company’s sales of Tecfidera, Spinraza and bios…

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