4.8 • 440 Ratings
🗓️ 14 August 2023
⏱️ 23 minutes
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0:00.0 | Last week, the FDA approved the first oral medication for postpartum depression, and today |
0:06.5 | I'll bring you 10 things you need to know about Zarel alone. |
0:14.8 | Welcome to the Carlatte Psychiatry podcast. I'm Chris Aiken, the editor-in-chief of the Carlat |
0:20.2 | Psychiatry Report, and our co-host |
0:22.8 | Kelly Newsom is out today on vacation. The FDA approved Xeranolone, brand name Zerzouva, |
0:31.5 | for postpartum depression last week. The approval was a Pyrrhic victory for Sage Therapeutics, the company that developed the |
0:39.1 | drug to replace its predecessor, Brexanalone, the cumbersome IV drug that was approved for |
0:45.2 | postpartum depression in 2019 as Zoresso. Brexanolone, Zoresso, was a scientific breakthrough, but not a financial success. |
0:57.7 | Sage had to lay off half its workforce shortly after the drug's release. |
1:03.5 | The drug worked well, but it was hard to deliver, requiring an overnight IV infusion, |
1:09.4 | oxygen checks because Brexenolone is so sedating that it can knock people unconscious. |
1:15.0 | Think back to 2020 when Brexenolone was first hitting the pharmacy shelves and COVID precautions were in full swing. |
1:23.7 | Were you in any position to open an overnight IV clinic then? |
1:38.1 | Probably not. Even hospitals didn't rise to the occasion. Most of us were trying to figure out how to deliver care with as little contact as possible back then. |
1:47.7 | Only about 1,000 women have received brachshenolone, and the minuscule market has not helped its pricing. |
1:55.1 | A single treatment costs $34,000 for the drug alone, and more for the overnight monitoring. |
2:02.0 | So Sage was hoping to break out of this morass with an oral version that women could take at home, |
2:04.9 | and that is where Zoran alone comes in. |
2:10.6 | Zoran alone is sedating, but so far no one has lost consciousness on it. |
2:15.8 | It comes with a simple warning, though, not to drive for 12 hours after taking it. |
2:19.3 | Just dose it all at night, and do take that warning seriously because there is evidence of driving impairment within those 12 hours. And Zareloan |
2:25.8 | has the bioavailability that Brexenolone lacked, so it can be taken orally, although it does |
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