Latest news with #antipsychotic
Reuters
4 days ago
- Health
- Reuters
US FDA advisers recommend against Otsuka's PTSD combination treatment
July 18 (Reuters) - The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's (4578.T), opens new tab antipsychotic drug in combination with Viatris' (VTRS.O), opens new tab antidepressant Zoloft for treating adults with PTSD. The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination with Zoloft, chemically known as sertraline, for treating the condition. Its decision is in line with the FDA staff reviewers' assessment on Wednesday. Otsuka's application was based on the data from one mid-stage and two late-stage studies testing the combination treatment compared to sertraline plus placebo. It had failed to meet the main goal of significantly reducing severity of PTSD symptoms in one of the late-stage studies compared to sertraline and placebo. PTSD, a disorder caused by very stressful events, affects about 4% of U.S. adults and is commonly associated with war veterans. But natural disasters, abuse or other trauma may also trigger the condition in civilians. "We simply cannot negate one negative study and say we are going to approve based on two other positive studies," said panelist Pamela Shaw, biostatistician at Kaiser Permanente. Otsuka did not immediately respond to a Reuters request for comment. The advisers discussed possible side-effects such as weight gain and movement disorders associated with long-term use of antipsychotics, but noted that the combination may be a better treatment option for patients who respond poorly to sertraline alone. "The big question for me is knowing that antipsychotics can cause real problems, especially with long-term use, and the modest benefit that the combination treatment potentially can offer," said panelist Walter Dunn, assistant clinical professor of psychiatry at university of California Los Angeles. The FDA, originally set to decide on the company's application by February 8, delayed its decision to seek the advisory panel's input. The agency has not set a new action date for the drug. The health regulator typically follows the advice of its expert advisers, but is not required to do so. If approved, the combination drug would be the first PTSD treatment to gain U.S. nod in more than two decades after Zoloft and GSK's (GSK.L), opens new tab Paxil. Brexpiprazole, branded as Rexulti, is approved in the U.S. to treat agitation in patients with Alzheimer's disease as well as for adults with major depressive disorder and schizophrenia. The drug is being co-developed by Otsuka and Danish drugmaker Lundbeck ( opens new tab.
CNN
5 days ago
- Entertainment
- CNN
Lewis Capaldi says antipsychotic medication ‘changed my life'
Lewis Capaldi says that he is taking antipsychotic medication and that it has changed his life. The Scottish singer stepped away from the public eye following a difficult performance at the Glastonbury Festival in the summer of 2023. His fans stepped in to help him finish hit song 'Someone You Loved' during that performance as he appeared to struggle on stage. Capaldi returned to the hugely popular British festival last month and is embarking on a sold out tour of the UK and Ireland in September, followed by a series of dates in Australia and New Zealand. The 28-year-old singer-songwriter opened up about his mental health struggles in an interview with Theo Von on YouTube. Speaking on the comedian's podcast 'This Past Weekend,' Capaldi said he'd had 'a breakdown of sorts on stage' at the festival two years ago. He revealed that an initial prescription for antidepressants made him feel 'numb,' while coming off them made him feel 'really low.' The shift to antipsychotic medication made all the difference, he said. 'It was really scary when they offered it up,' he said, adding that he questioned the prescription, saying: 'I'm not psychotic.' He said he takes aripiprazole, which is known to be a treatment for Tourette's Syndrome, as well as other conditions like bipolar disorder and schizophrenia. 'It's changed my life,' he said. 'It's genuinely been a massive, massive help.' He said he's been having therapy and that he's also made other lifestyle changes: he has cut back on drink, changed his diet and taken up exercise, revealing that he has lost about 28 pounds since January. 'My anxiety levels are so low these days,' he said. 'I don't feel as stressed. I don't know if it's all related to this (the antipsychotics) or other choices – I guess it's an amalgamation of things.' The performance at Glastonbury in 2023 was 'the lowest moment of my life,' Capaldi said, adding: 'I had this moment where I was on stage, like two, three songs in, (thinking) this is the last time I'm going to play a gig for a long time. I need to try and get through the rest of the show but when I come off I'm done.' That decision, he said, left him feeling like a 'weight had been lifted.' There had been a similar episode several weeks earlier in Chicago, which he said was 'way worse.' 'I couldn't come back on stage and finish the song and I was backstage convulsing and having this crazy panic attack,' he said. 'In a weird way it's probably the best thing that's ever happened to me, that moment at Glastonbury in 2023, because… I wouldn't have stopped otherwise.' CNN's Lisa Respers contributed to this report.
CNN
5 days ago
- Entertainment
- CNN
Lewis Capaldi says antipsychotic medication ‘changed my life'
Lewis Capaldi says that he is taking antipsychotic medication and that it has changed his life. The Scottish singer stepped away from the public eye following a difficult performance at the Glastonbury Festival in the summer of 2023. His fans stepped in to help him finish hit song 'Someone You Loved' during that performance as he appeared to struggle on stage. Capaldi returned to the hugely popular British festival last month and is embarking on a sold out tour of the UK and Ireland in September, followed by a series of dates in Australia and New Zealand. The 28-year-old singer-songwriter opened up about his mental health struggles in an interview with Theo Von on YouTube. Speaking on the comedian's podcast 'This Past Weekend,' Capaldi said he'd had 'a breakdown of sorts on stage' at the festival two years ago. He revealed that an initial prescription for antidepressants made him feel 'numb,' while coming off them made him feel 'really low.' The shift to antipsychotic medication made all the difference, he said. 'It was really scary when they offered it up,' he said, adding that he questioned the prescription, saying: 'I'm not psychotic.' He said he takes aripiprazole, which is known to be a treatment for Tourette's Syndrome, as well as other conditions like bipolar disorder and schizophrenia. 'It's changed my life,' he said. 'It's genuinely been a massive, massive help.' He said he's been having therapy and that he's also made other lifestyle changes: he has cut back on drink, changed his diet and taken up exercise, revealing that he has lost about 28 pounds since January. 'My anxiety levels are so low these days,' he said. 'I don't feel as stressed. I don't know if it's all related to this (the antipsychotics) or other choices – I guess it's an amalgamation of things.' The performance at Glastonbury in 2023 was 'the lowest moment of my life,' Capaldi said, adding: 'I had this moment where I was on stage, like two, three songs in, (thinking) this is the last time I'm going to play a gig for a long time. I need to try and get through the rest of the show but when I come off I'm done.' That decision, he said, left him feeling like a 'weight had been lifted.' There had been a similar episode several weeks earlier in Chicago, which he said was 'way worse.' 'I couldn't come back on stage and finish the song and I was backstage convulsing and having this crazy panic attack,' he said. 'In a weird way it's probably the best thing that's ever happened to me, that moment at Glastonbury in 2023, because… I wouldn't have stopped otherwise.' CNN's Lisa Respers contributed to this report.
Medscape
19-06-2025
- Health
- Medscape
Weekly Pill Succeeds in Schizophrenia, With Broader Promise
A novel once-weekly capsule loaded with the antipsychotic risperidone, LYN-005, provided similar bioavailability and symptom control as daily doses of the drug in a phase 3 trial of patients with schizophrenia or schizoaffective disorder. The study was stopped early for success after an interim analysis showed all pharmacokinetic values met primary endpoint criteria. Weekly LYN-005 could bridge the gap between daily oral medications and long-acting injectable antipsychotics, which are not universally offered or accepted by patients, the researchers noted. 'One of the biggest obstacles in the care of people with chronic illness in general is that medications are not taken consistently. This leads to worsening symptoms, and in the case of schizophrenia, potential relapse, and hospitalization,' lead author Leslie Citrome, MD, MPH, New York Medical College School of Medicine, Valhalla, New York, said in a news release. 'Having the option to take medication by mouth once a week represents an important option that can assist with adherence for the many patients who would prefer oral medications vs injectable formulations,' he added. The study was published online on June 10 in The Lancet Psychiatry . More Than a Decade in the Making The investigational capsule is about the size of a multivitamin and once ingested, the pill unfolds into a star shape designed to prevent it from being passed from the stomach while the drug is released. Over time, enteric and time-dependent layers on the prongs of the star become more pliable and/or break off, easing passage out of the stomach and through the intestinal tract. Initial details of the drug-delivery platform were reported in 2016 by researchers at the Massachusetts Institute of Technology, Cambridge, Massachusetts, and Brigham and Women's Hospital, Boston, with further development of the star capsule by the current study sponsor, Lyndra Therapeutics. The STARLYNG-1 trial enrolled 83 patients, aged 18-64 years, across five US sites who had schizophrenia or schizoaffective disorder for at least 2 years and were stabilized on any oral antipsychotic drug for 6 weeks or longer. Participants were also required to have no hospital admission for worsening schizophrenia within the past 6 months, a Clinical Global Impressions Scale-Severity score ≤ 4, and a Positive and Negative Syndrome Scale (PANSS) score ≤ 80. After a 7-day run-in period with immediate-release daily risperidone (2 mg or 6 mg), participants received five weekly doses of LYN-005 (15 mg or 45 mg, respectively), with a supplemental half-dose of daily immediate-release risperidone during week 1 of LYN-005 dosing. Participants were inpatients from day -5 to day 8 and from day 14 to the end of treatment and participated as outpatients on days 9-13 to ensure consistent blood sampling and treatment compliance. They were followed for safety for 4 weeks after treatment. Medications for agitation, anxiety, and insomnia were permitted during the study and nine participants received rescue risperidone. In all, 47 participants completed the study and 44 were included in the pharmacokinetic analysis. Sustained Release, No Unexpected Safety Signal The primary endpoints were the minimum concentration (C min ) of the active moiety of LYN-005 at weeks 1 and 5, and the maximum concentration (C max ) and average concentration (C avg ) of the active moiety of LYN-005 at week 5 compared with immediate-release risperidone on day -1. Geometric mean ratios (GMRs) of LYN-005 vs immediate-release risperidone were 1.02 for C min at week 1 (90% CI, 0.93-1.12), and 1.04 for C min (90% CI, 0.87-1.23), 0.84 for C max (90% CI, 0.77-0.92), and 1.03 for C avg (90% CI, 0.93-1.13) at week 5. LYN-005 concentrations were maintained above the target threshold (C min : GMR, 1.04) and remained below peak concentrations of immediate-release risperidone, suggesting stable drug delivery over time, the authors noted. Changes in mean PANSS total scores were minimal regardless of LYN-005 dose and scores were maintained in the mid-50s throughout treatment, indicating relatively mild symptom severity and stable disease control with LYN-005, they added. Among 67 participants who received at least one dose of LYN-005, 56 (84%) had at least one adverse event and nine (13%) participants had an event that led to study withdrawal. Gastrointestinal-related events were the most common (66%) and most were mild (75%) and lasted < 3 days. GI events that persisted for more than 3 days included gastroesophageal reflux disease, dyspepsia, and constipation. Other common adverse events were headache (12%), nausea (10%), and back pain (8%). One serious treatment-emergent adverse event (esophagitis) was reported during follow-up and resulted in full recovery. There were no fatal adverse events. Mean Somatic Symptom Scale-8 scores were none to minimal (0-3 score) across the 5 weeks and were weakly correlated with the number of gastrointestinal-related adverse events reported over the same period. Two thirds (68%) of patients and 53% of physicians reported a score ≥ 3 on a 5-point Likert scale, with 1 being very dissatisfied and 5 very satisfied with LYN-005. 'It works and the whole point of treating schizophrenia is adherence, getting them to take the medicine,' Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford University School of Medicine, Stanford, California, told Medscape Medical News . 'Some patients will take it oral; some take it injectable; and there are some patients who are very resistant. This sounds like another way a doctor can try.' The investigators acknowledge that the relatively stable trial population does not represent the heterogeneity seen in clinical practice and that strict inclusion criteria might limit generalizability to the broader schizophrenia population. Other limitations include few female participants (25%) and that the controlled clinical setting with structured support and regular inpatient monitoring might have allowed for greater adherence. The double-blind, placebo-controlled trial STARLYNG-2 trial was to evaluate the long-term safety and tolerability of LYN-005 but the trial was withdrawn in April 2025. Lyndra Therapeutics is investigating the use of the star capsule to deliver other drugs, including weekly levomethadone for treatment of opioid use disorder, monthly contraceptives, and an oral biweekly ivermectin for malaria, according to the company website.
