“Hooray for Biogen and Sage Therapeutics!” exclaimed the US Food and Drug Administration (FDA) as they gave their blessing this fine Friday to the oral pill these companies created to battle postpartum depression (PPD) among adults
Biogen and Sage Therapeutics had their hearts set on making Zurzuvae, the drug in question, a weapon against the monstrous major depressive disorder (MDD) or clinical depression. Both disorders are not to be taken lightly, for they cast a gloomy shadow over the lives of millions.
It’s no secret that PPD can throw a monkey wrench into a woman’s life. Picture trying to get back to your daily routine while battling this beast. Not to mention the possible strain it could place on the tender bond between a mother and her child.
In the blink of an eye, Zurzuvae will hit the shelves, becoming readily available for purchase in the last quarter of 2023. This follows a necessary process where it will be declared a controlled substance by the US Drug Enforcement Administration. The heads at Sage Therapeutics and Biogen forecast this happening within the next three months.
There was, however, a slight hiccup. The FDA put a spanner in the works when it came to approving Zurzuvae for treating adults with MDD. They served up a Complete Response Letter for the New Drug Application for Zurzuvae, basically saying that there’s just not enough proof that this drug can really tackle MDD. This means additional studies are needed to give the FDA confidence in the drug’s effectiveness.
Sage and Biogen are taking this feedback to heart and are mulling over their next steps. In the meantime, market gurus were sitting on pins and needles, predicting that the company stocks would take a plunge if the drug got the green light for PPD alone due to the smaller number of potential users.
Until this point, the only way to wrestle with postpartum depression was through an intravenous injection, according to the FDA. But now, hope is on the horizon.
In 2021, a whopping 21 million adults in the United States found themselves in the grip of at least one episode of major depressive disorder, which can be recognized by a lingering feeling of sadness. Meanwhile, PPD snuck up on roughly one in seven women who welcomed a new bundle of joy into the world.
