Med Check

Indivior Submits NDA For LAI Risperidone

Indivior Inc. has submitted a New Drug Application (NDA) to the Food and Drug Administration for its investigational compound RBP-7000, a once-monthly injectable formulation of risperidone that uses Indivior’s Atrigel delivery system. Atrigel is a biodegradable polymer that enables the controlled release of drugs in the bloodstream.

The NDA submission includes the results from both a randomized, placebo-controlled phase 3 study of inpatients with an acute exacerbation of schizophrenia and an open-label, long-term safety study. Patients taking RBP-7000 during the eight-week phase 3 study demonstrated statistically significant improvements in both their Positive and Negative Syndrome Scale scores and Clinical Global Impression-Severity of Illness scores compared with placebo.

5-HT6 Inhibitor Fails in Late-Stage Alzheimer’s Trial

Patients aged 50 to 85 with Alzheimer’s disease who took intepirdine, an inhibitor of the serotonin receptor 5-HT6, in addition to donepezil therapy for 24 weeks appeared no different from those taking placebo, according to Axovant Sciences, the developer of the investigational drug.

A once-daily oral dose of 35 mg intepirdine was not superior to placebo on two widely used Alzheimer’s symptom measures: the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory.

5-HT6 inhibitors like intepirdine promote the release of acetylcholine, a neurotransmitter important for alertness, memory, and judgment. It had been hoped that this class of drugs might work in tandem with other neurotransmitter-boosting drugs such as cholinesterase inhibitors or NMDA antagonists.

Axovant is evaluating the effects of daily intepirdine in patients with Lewy body dementia. The topline results of this trial are expected to be available by the end of the year.

Cannabinoid Compound Improves Fragile X Symptoms

The results of a phase 2 trial of ZYN002 cannabidiol (CBD) gel suggest the medication may help reduce anxiety and depression in patients with fragile X syndrome.

The study successfully met its primary endpoint, achieving a 46 percent improvement in the total score of Anxiety, Depression, and Mood Scale at week 12 from baseline.

ZYN002 was also associated with meaningful improvements in all measures of the Aberrant Behavior Checklist for fragile X, including social avoidance, temper tantrums, repetitive movements, and hyperactivity.

The phase 2 study involved only 20 participants aged 6 to 17 with fragile X and did not include a control arm. Other studies involving medications for fragile X have indicated a placebo response in relation to mood improvements.

In a press release, Zynerba, the developers of ZYN002, noted that the company hopes to meet with the FDA in 2018 to discuss moving testing into a phase 2/3 program. The FDA has granted Zynerba Orphan Drug designation for the use of cannabidiol as a fragile X syndrome treatment.

FDA Rejects Request to Consider Cariprazine for Treating Negative Symptoms

The FDA has refused Allergan’s request to review a Supplemental New Drug Application (sNDA) to expand the approved uses of the antipsychotic Vraylar (cariprazine) to include negative symptoms of schizophrenia. Currently, Vraylar is indicated for the general treatment of schizophrenia as well as the acute treatment of manic or mixed episodes in adults with bipolar I disorder.

Upon its preliminary review, the FDA determined that Allergan’s sNDA for treatment of negative symptoms was not sufficiently complete to permit a substantive review.

“We are disappointed with the FDA decision on our submission,” Allergan Chief Research and Development Officer David Nicholson, Ph.D., said in a press release. “We remain committed to our mental health program and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia.”

FDA Clears Neurostimulator For Chronic Pain

The FDA has approved Medtronic’s Intellis spinal cord stimulation platform for the management of chronic intractable pain associated with a variety of conditions.

Intellis, described by Medtronic as “the world’s smallest implantable spinal cord stimulator,” offers personalized levels of neurostimulation that can be wirelessly adjusted by the physician using a Samsung Galaxy tablet as pain shifts or changes intensity.

The Intellis platform also includes comprehensive activity tracking and sharing features to improve patient-physician communication. By tracking daily activities, body positions, and therapy use on the tablet, physicians can get an objective look at patient mobility and progress.

The Samsung tablets come installed with HIPAA-compliant security software.

These new devices will also feature improved battery technology that enables a full battery recharge of the stimulator in approximately one hour. ■