Psychiatry in the News: January 2024

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Here’s some news you may have missed in the world of psychiatry from throughout the month of January, as featured in Psychiatric Times®.

Oral Weekly Risperidone for Schizophrenia: Positive Phase 3 Study Data

Lyndra Therapeutics announced positive data from the STARLYNG-1 study, which compared the pharmacokinetic profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily for adults with schizophrenia and schizoaffective disorder.

The study assessed oral weekly risperidone 15 mg and 45 mg, which is equivalent to 2 mg and 6 mg daily Risperdal, respectively. Participants included individuals with schizophrenia and schizoaffective disorder who were on a stable oral antipsychotic dose at the start of the study; a total of 90 participants were planned, with an interim analysis after 46 participants. Oral weekly risperidone met the endpoint of a one-sided Cmin of >0.80; a one-sided Cmax of <1.25; and a 2-sided Cavg of 0.80-1.40, with 90% confidence limits. The study also met secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score. Oral weekly risperidone (LYN-005) was generally safe and well tolerated. Continue Reading

First FDA-Approved Self-Neuromodulation Device for PTSD Officially Launches in the US

GrayMatters Health, a developer of digital self-neuromodulation therapies for mental health care, announced today that it has officially launched Prism for posttraumatic stress disorder (PTSD) in the United States.

Prism for PTSD—the first self-neuromodulation device to receive US Food & Drug Administration (FDA) clearance as a prescribed adjunct to standard of care (SOC) for PTSD—is now accessible at 2 US clinics, with several more clinics currently in the process of installing and training with Prism for PTSD.Clinics adopting Prism for PTSD have the added value of being able to leverage existing business models, which provides opportunities to add revenue-generating services while enhancing treatment outcomes. Continue Reading

Phase 3 Topline Results Support Sustained Efficacy, Tolerability of Treatment for Schizophrenia, Bipolar I Disorder

Alkermes plc released topline results from a phase 3, open-label extension study assessing the extended safety, tolerability, and treatment effect durability of Lybalvi (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder, or bipolar I disorder over up to 4 years of treatment.

“We are pleased to share the topline results from this long-term, open-label study,” said Craig Hopkinson, MD, executive vice president of research and development and chief medical officer at Alkermes, in a press release. “These data highlight the potential utility of Lybalvi as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder and reinforce the safety profile of Lybalvi established in previous studies.” Continue Reading

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