The Week in Review: June 3-7

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from the FDA’s decision about MDMA-assisted therapy to a look at the new data on seltorexant for MDD and insomnia.

FDA Panel Votes Against MDMA-Assisted Therapy

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The US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted against the approval of MDMA-assisted therapy for the treatment for posttraumatic stress disorder (PTSD) last night, Tuesday, June 4.

Panel experts weighed the need for new PTSD treatments against the concerns with data submitted by Lykos Therapeutics. While MDMA seemed to have a positive effect on many participants in the 2 phase 3 clinical trials, MAPP1 and MAPP 2, several issues swayed the vote in the negative. Cited reasoning included faulty study design and ethical violations. Continue Reading

First Patient Dosed in Pharmacokinetics Study of AD04 for Alcohol Use Disorder

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Adial Pharmaceuticals Inc announced that the first patient has been dosed in its pharmacokinetics study of AD04 for the treatment of alcohol use disorder (AUD).

“Dosing our first patient is an important milestone, marking the beginning of clinical activity in this previously planned and pre-budgeted study,” said Cary Claiborne, president and CEO of Adial Pharmaceuticals, in a press release. “Our goal is to obtain data we need to design a more precise and informed phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the US Food and Drug Administration (FDA) and is intended to enhance the likelihood of success in our upcoming phase 3 trial.” Continue Reading

Everyone Is Wrong About Benzodiazepines

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The Wall Street Journal recently published an essay entitled, “The Danger of Relying on Anti-Anxiety Drugs,” by Jenny Taitz, PsyD. The article is gracefully written and reasonably well-informed. Taitz appears sympathetic to her patients and open to a variety of opinions from experts and critics alike. But there is nothing even slightly new or original in her content.

It perfectly articulates the opinions of the vast majority of educated nonpsychiatrists on the subject of psychiatric medications in general, and benzodiazepines in particular. These talking points and assorted opinions have not changed significantly in the past 4 decades, which might give one the impression that such an article is of no interest. Yet I think such a quick dismissal would be a mistake. Continue Reading

Seltorexant, Major Depressive Disorder, and Insomnia: Thoughts on the New Data

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Psychiatric Times sat down with Wayne Drevets, MD, and Andrew Krystal, MD, to discuss the recent data on seltorexant, an investigational first-in-class therapy in major depressive disorder (MDD) with insomnia symptoms, presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.

PT: How can clinicians screen for insomnia in their patients with MDD? How often is it comorbid?

Andrew Krystal, MD: It should be routine for all clinicians to assess for insomnia among patients being evaluated or treated for depression. This is because insomnia is one of the cardinal symptoms of MDD and, as a result, is among the diagnostic criteria which all must be reviewed in order to determine a diagnosis. That insomnia is among the diagnostic criteria for MDD is consistent with the fact that the available literature suggests that approximately 70% of those with MDD suffer from insomnia. Continue Reading

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