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Press Releases

Take a look at a selection of our recent media coverage:

Links between aripiprazole and gambling disorder highlighted in new drug safety update

19th December 2023

Healthcare professionals prescribing aripiprazole for schizophrenia and bipolar disorder should be alert to the known risk of patients developing addictive gambling, according to a new drug safety update.

This reminder about aripiprazole from the Medicines and Healthcare products Regulatory Agency (MHRA) comes after a rise in the number of reports of gambling or gambling disorder it received in 2023.

Between 1 January and 31 August 2023, the MHRA’s Yellow Card scheme received 32 reports of gambling or gambling disorder where aripiprazole was suspected to be the cause.

In the last 14 years, there have been 69 reports, making the 2023 figures over 46% of the total.

The MHRA asked gambling clinics in March 2023 to report any suspected cases, which may account for some of the rise, it said.

The UK reports of this suspected addictive behaviour occurred in patients both with and without a history of problem gambling and most reported that the urges resolved on reducing the dose or stopping treatment with the drug.

The MHRA is advising patients to tell their doctor if they or their family and friends notice they are having unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive.

And it warned that patients should continue taking aripiprazole as advised, as stopping the drug without medical advice can be harmful.

Alison Cave, MHRA chief safety officer, said: ‘The number of reports for suspected gambling and other impulsive behaviours associated with aripiprazole are small in comparison to the frequency with which it is prescribed, but the consequences for any patient developing these conditions can be significant.

She also highlighted that ‘aripiprazole is an effective and acceptably safe drug for many people.’

Professor Henrietta Bowden-Jones, director of the National Problem Gambling Clinic, added: ‘Clinicians prescribing aripiprazole must commit to consistently alert patients about these potential risks, both during the initial prescription and follow-up reviews.’

This includes asking patients if they have a personal history of excessive gambling or any other impulsive behaviours before prescribing aripiprazole.

Trial finds xanomeline-trospium combination effective in schizophrenia

6th April 2023

Xanomeline-trospium an oral, investigational M1/M4-preferring muscarinic agonist significant improved symptoms in patients with schizophrenia

In a press release from the manufacturer Karuna Therapeutics, it was announced that its lead investigational therapy, xanomeline-trospium, demonstrated a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo, in adults with schizophrenia.

Schizophrenia is a psychotic disorder characterised by positive symptoms, such as hallucinations, delusions, formal thought disorders, and negative symptoms, such as paucity of speech, anhedonia, and lack of motivation. Xanomeline is a muscarinic agonist (M1 and M4) and has been shown to improve all symptoms types of schizophrenia. However, drug development was stopped due to the severe cholinergic adverse effects but when used in combination with the peripheral cholinergic antagonist, trospium, it is expected that the latter can reduce the adverse effects of xanomeline. Early findings to date have been positive and in a 5-week trial, randomised, double-blind, placebo-controlled trial, xanomeline-trospium produced a greater decrease in the PANSS total score than placebo 2.

The current press release relates to the EMERGENT-3 Trial, a phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre study, with xanomeline-trospium in patients with schizophrenia. The primary objective was to assess the efficacy of xanomeline-trospium (125 mg xanomeline and trospium chloride 30 mg) given twice daily, at reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia.

A total of 256 adults (between the ages of 18-65 years) with schizophrenia were included in the trial and were experiencing symptoms of psychosis at the time of enrolment. In the trial, patients were randomised 1:1 to receive either a flexible dose of xanomeline-trospium or placebo twice daily for five weeks. On days 1-2, patients received a dose of 50mg xanomeline/20mg trospium) twice daily or matching placebo. On Day 3, patients escalated to a dose of 100/20 twice daily and on Day 8, patients had the option to increase to 125/30 twice daily, based on tolerability.

Xanomeline-trospium in EMERGENT-3

The trial met its primary endpoint, with xanomeline-trospium showing a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-20.6 vs. -12.2 placebo, p < 0.0001) at Week 5. In fact, the combination demonstrated an early and sustained statistically significant reduction of symptoms from Week 2 (p < 0.05) through the end of the trial as assessed by PANSS total score.

The overall discontinuation rate in the trial was 33% (37% xanomeline-trospium vs. 29% placebo) with the overall treatment emergent adverse event (TEAE) rates slightly higher for the combination compared to placebo (70% vs 50%).

The press release also reports that the company will submit data to the FDA mid-2023 and hopefully, if approved will look to launch the drug in 2024.