FDA warns against compounded oral ketamine for psychiatric disorders

[3D model of Ketamine from Wikimedia Commons]

In recent years, interest in the use of oral ketamine has surged for mood disorders, thanks to the marketing efforts of companies like Mindbloom, Better U, Nue Life and Joyous. FDA released a statement describing the risks involved in taking compounded oral ketamine, noting that the dissociative anesthetic is not FDA approved for any psychiatric disorder. 

Compounded oral ketamine risks

The agency specifically warned against the use of compounded ketamine without proper medical oversight, warning that sedation, dissociation, and vital sign changes “may put patients at risk for serious adverse events.” 

The FDA’s warning included several considerations related to the use of compounded ketamine for psychiatric disorders, including its potential for abuse and misuse. The agency also noted that ketamine use could lead to psychiatric events, given its associa…

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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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Study suggests mGlyR could be a promising antidepressant target

A model illustrates glycine molecules (teal) interacting with GPR158 brain cell receptors, influencing the nervous system. [Martemyanov lab, The Wertheim UF Scripps Institute]

A study published in Science has revealed important information about a brain receptor known as  mGlyR, which could be a potential antidepressant target. An abbreviation of “metabotropic glycine receptor,” mGlyR is highly active in the brain’s medial prefrontal cortex (mPFC). Abnormal activity in the brain region is associated with depression.

Formerly known as GPR158, mGlyR is a specific brain receptor type that responds to certain chemical signals. In addition to depression, researchers have linked mGlyr to cancer development and cognition. GPR158 directly interacts with a chemical known as glycine, which plays a role in various brain functions.

Both glycine and aurine affect mGlyR. Researchers believe these chemicals …

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