Med Check: Unapproved, Misbranded Opioids; Treating Adults With ADHD; Improve Cognition in Patients With Schizophrenia

FDA Warns Websites Hawking Unapproved, Misbranded Opioids

In September the U.S. Food and Drug Administration (FDA) sent warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online. Misbranded opioids include those offered for sale without a prescription and opioids that lack adequate directions for use. Tramadol and oxycodone are among the opioids being offered for sale, and several of the websites offer opioids online without a prescription.

“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release.

The agency noted in the release that people who buy prescription drugs, including opioids, from illegal online pharmacies may put their health at risk because the products may be counterfeit, contaminated, expired, or otherwise unsafe. The agency added that illegal online pharmacies can also pose other risks to consumers, including credit card fraud, identity theft, and computer viruses.

AR19 Shows Promise for Adults With ADHD

In September Arbor Pharmaceuticals LLC announced positive safety and efficacy results from a phase 3 study in adults of AR19, its investigational immediate-release, amphetamine sulfate capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD). The drug is designed to resist manipulation for non-oral use such as snorting, smoking, or injecting and is currently under review by the FDA.

In the study, 320 adults aged 18 to 55 years with ADHD were randomized to receive 20 mg of AR19, 40 mg of AR19, or placebo daily for five weeks. Researchers measured improvement according to the Adult ADHD Investigator Symptom Rating Scale. At the fifth week, patients in either group who took AR19 dropped roughly 7 more points on the scale than the placebo group dropped. The most common side effects, which were reported by more than 5% of patients who took AR19, were insomnia, dry mouth, lowered appetite, palpitations, and tachycardia.

FDA Receives NDA for Parkinson’s Drug SPN-830

Supernus submitted a New Drug Application (NDA) in September for SPN-830, its apomorphine infusion pump for the continuous treatment of on-off episodes in adults with Parkinson’s disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy. During off episodes, motor symptoms like stiffness or tremor return even though the patient is taking medication for PD.

The company submitted the NDA based on the results of the phase 3 TOLEDO study (conducted in Europe) and an open-label study (conducted in the United States). Both 12-week studies included adults with average daily off episodes that lasted at least three hours. All patients kept diaries of their motor symptoms.

In the TOLEDO study, 106 patients received either SPN-830 or placebo. The mean daily off time decreased a mean of 2.47 hours for those in the SPN-830 group compared with a mean decrease of 0.58 hours in the placebo group. In the U.S. study, all 94 patients took SPN-830 and their mean daily off episodes decreased by three hours. Most of the side effects reported by patients were mild or moderate and included problems at the infusion site, nausea, and dyskinesia.

BI 425809 May Improve Cognition in Patients with Schizophrenia

Boehringer Ingelheim’s investigational compound BI 425809 improved cognition in stable adult patients with schizophrenia in a phase 2 trial, the company announced in September.

In the study, patients with schizophrenia in 11 countries were randomized to receive either 2 mg to 25 mg of BI 425809 or placebo daily for 12 weeks. All patients were medically stable with no hospitalization for worsening of schizophrenia in the three months before randomization. They were also psychiatrically stable with no exacerbations in their symptoms in the three months before randomization.

At 12 weeks, cognitive function improved in patients who took BI 425809, as measured by the composite Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery. This series of tests assesses patients’ speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. There were no differences in psychiatric adverse events or suicidality between groups. ■