Med Check: Alzheimer’s Therapy; Adhansia XR; Dasotraline for Binge-Eating Disorder; Somryst for Insomnia; Nuplazid

Positive Phase 2 Results for Alzheimer’s Therapy

Participants in a phase 2 trial who received Alkahest Inc.’s investigational therapy for mild-to-moderate Alzheimer’s disease, GRF6019, showed no decline in cognition or functional status over a period of six months, the company announced in August. GRF6019—a plasma-derived product developed by the health care company Grifols—was previously shown in animal models to reduce neuroinflammation and age-related deficits in learning and memory.

Forty adults aged 60 years or older with a diagnosis of probable Alzheimer’s disease (based upon the National Institute on Aging–Alzheimer’s Association criteria) participated in the six-month trial. They were randomized to be treated intravenously with 100 mL or 250 mL of GRF6019 for five consecutive days during the first week of the trial and again for five consecutive days in week 13.

At study’s end, participants had no decline in cognition, as measured by the 11-item Alzheimer’s Disease Assessment Scale-cognitive subscale and the Mini-Mental State Examination.

Adhansia XR Now Available for ADHD in US

Adhansia XR (methylphenidate hydrochloride extended release), a central nervous system stimulant by Adlon Therapeutics for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older, became available in the United States in July. The medication comes with a boxed warning for abuse and dependence.

Adhansia XR is available in six capsule strengths: 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg. The recommended starting dose of Adhansia XR for patients aged 6 years or older is 25 mg once daily. The company recommended that health care professionals titrate the dose in increments of 10 mg to 15 mg at intervals of no less than five days. Dosages higher than 100 mg daily in adults and 85 mg daily in children have not been evaluated in clinical trials and are not recommended.

Four clinical trials evaluated the efficacy and safety of Adhansia XR in patients with ADHD: two studies in adults, one trial over a 13-hour study day in patients aged 6 to 12 years, and one safety and efficacy study in patients aged 12 to 17 years. Patients in all studies who received Adhansia XR achieved statistically significant improvement in symptoms compared with those who received placebo.

Sunovion Seeks Approval for Dasotraline for Binge-Eating Disorder

Sunovion has submitted a New Drug Application to the Food and Drug Administration (FDA) for dasotraline for the treatment of adults with moderate-to-severe binge-eating disorder (BED). Dasotraline is a novel, once-daily dopamine and norepinephrine reuptake inhibitor with an extended half-life.

Dasotraline was evaluated in two 12-week, randomized, placebo-controlled studies, SEP360-221 and SEP360-321. The first study, SEP360-221, was a phase 2/3 trial comparing dasotraline with placebo in adults aged 18 to 55 years with moderate-to-severe BED. Participants took 4 mg to 8 mg of dasotraline once a day or placebo. At the end of 12 weeks, participants who took dasotraline had fewer binge days, defined as days during which at least one binge episode occurred, compared with those in the placebo group.

The second study, SEP360-321, was a phase 3 trial comparing dasotraline with placebo in adults aged 18 to 55 years with moderate-to-severe BED. Participants received once-daily doses of 4 mg or 6 mg of dasotraline or placebo. The study met its primary endpoint and demonstrated a statistically significant decrease in the number of binge days per week at week 12 in the group treated with dasotraline 6 mg per day compared with the placebo group.

Pear Seeks FDA OK to Market Somryst for Insomnia

In July Pear Therapeutics filed for FDA permission to market its prescription digital therapeutic Somryst for the treatment of adults with chronic insomnia and depression. Prescription digital therapeutics use software applications to treat disease. Somryst is designed to provide online cognitive-behavioral therapy for insomnia.

In a trial of more than 1,100 adults with chronic insomnia and depression, the treatment group received Somryst, and the placebo group received a digital placebo along with usual care. At the end of nine weeks, participants in the treatment group experienced a reduction in their mean Insomnia Severity Index scores from 15.92 at baseline to 7.27, compared with a reduction from 16.23 to 13.17 in the placebo group.

The treatment group also showed a reduction in mean Patient Health Questionnaire-9 scores from 8.03 to 3.78, compared with a reduction from 7.84 to 6.2 in the placebo group. The majority of participants in the treatment group no longer met criteria for insomnia or depression at the end of the nine-week treatment.

Nuplazid Fails as Add-on Therapy for Schizophrenia

Adding Nuplazid (pimavanserin) to existing antipsychotic treatment improved psychotic symptoms in a six-week phase 3 trial of people with schizophrenia but ultimately did not meet the primary endpoint, Acadia Pharmaceuticals announced in July.

As part of the ENHANCE study, 396 patients with moderate-to-severe psychotic symptoms received either pimavanserin or placebo in addition to their current antipsychotic treatment for six weeks. The primary endpoint was a decrease in scores on the Positive and Negative Syndrome Scale, and the secondary endpoint was improvement in Clinical Global Impression–Severity scores. Although participants who took pimavanserin achieved improved scores on both of these scales, the results were not clinically significant.

Acadia is currently evaluating pimavanserin for adjunctive treatment of schizophrenia in patients with predominant negative symptoms in the 26-week phase 2 ADVANCE study. ■