Med Check: Fasedienol, Caplyta, Solanezumab, and Xanomeline-Trospium

A phase 3 trial of fasedienol nasal spray suggests that the drug helps relieve symptoms of social anxiety disorder in adults, Vistagen announced in March.

In the trial, 481 patients aged 18 to 65 years with social anxiety disorder took one 100 µL spray in each nostril up to four times a day as needed for acute anxiety for a year. The study participants were evaluated using the Liebowitz Social Anxiety Scale (LSAS) over the course of the trial. At 1, 2, and 3 months, 36%, 44%, and 55%, of patients experienced a 20-point or greater reduction on the LSAS, respectively. Those who continued in the study saw improvements each month through nine months.

At baseline, 50.3% of the patients were rated as “severely ill” or “among the most extremely ill patients” on the Clinician Global Impression–Severity of Illness Scale (CGI-S). At one month, 385 of the patients were assessed and only 21.8% of those patients remained in the “severely ill” or “among the most extremely ill” categories.

The trial was also designed to assess safety and tolerability. Among the 481 patients who received at least one dose of fasedienol, 56.8% reported at least one treatment-related adverse event, and 54.9% reported mild or moderate treatment-related adverse events such as headache.

Caplyta (lumateperone) may help reduce symptoms of major depressive disorder with mixed features and bipolar depression with mixed features, Intra-Cellular Therapies announced in March.

In a phase 3 trial, 383 adult patients who had either major depressive disorder with mixed features or bipolar depression with mixed features were randomized to receive 42 mg of lumateperone or placebo once daily in the evening. The patients’ symptoms were assessed via the Montgomery-Åsberg Depression Rating Scale (MADRS).

At the end of six weeks, the mean MADRS score dropped 5.9 points in patients with major depressive disorder with mixed features compared with their peers who took placebo. The mean MADRS score dropped 5.7 points in patients with bipolar depression with mixed features compared with their peers who took placebo. The most common adverse events, reported in at least 5% of patients who took lumateperone, were drowsiness, dizziness, and nausea.

In March Eli Lilly and Company announced that solanezumab did not slow the progression of cognitive decline due to Alzheimer’s disease in a study of patients who have amyloid plaque but no clinical symptoms of the disease (preclinical Alzheimer’s disease).

In the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) study, more than 1,100 patients aged 65 to 85 years with preclinical Alzheimer’s disease were randomly assigned to receive either solanezumab or placebo intravenously every four weeks for approximately 4.5 years. The primary endpoint was the change from baseline in the Preclinical Alzheimer Cognitive Composite (PACC), which tests episodic memory, timed executive function, and global cognition.

At the end of the study, PACC scores declined a mean of 1.69 points in patients who received solanezumab and 1.4 points for patients who received placebo. Furthermore, patients in both the treatment and placebo groups continued to accumulate amyloid over time.

Karuna Therapeutics Inc.’s investigational medication for the treatment of adults with schizophrenia KarXT (xanomeline-trospium) was shown to reduce symptoms of schizophrenia in adults in the phase 3 EMERGENT-3 trial, the company announced in March.

In the trial, 256 patients with schizophrenia who were experiencing psychosis were randomized to receive either KarXT or placebo twice daily for five weeks. The patients’ symptoms were assessed with the Positive and Negative Syndrome Scale (PANSS).

At the end of five weeks, PANSS total scores dropped a mean of 20.6 points in patients who took KarXT, compared with a mean reduction of 12.2 points in patients who took placebo. In addition, scores in the PANSS positive subscale dropped 7.1 points for patients who took KarXT compared with 3.6 points for those who took placebo.

The most common adverse events, reported in at least 5% of patients who took KarXT, were nausea, dyspepsia, vomiting, constipation, headache, hypertension, diarrhea, and insomnia, all of which were rated mild or moderate in severity. ■