Med Check: Loperamide; SPN-810; BNC210; Aducanumab; Reyvow; Trulicity

FDA Approves New Loperamide Packaging

In September the Food and Drug Administration (FDA) announced new package sizes and types for over-the-counter (OTC) loperamide, including Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules. The FDA had received reports of serious heart problems and death in people who intentionally misused loperamide by taking high doses of the drug.

Research suggests that some people who have opioid use disorder misuse loperamide to prevent or treat symptoms of withdrawal, and some may take massive doses to get high.

The new requirements limit each carton to no more than 48 mg of loperamide and mandates unit-dose blister packaging. The maximum approved dose of over-the-counter loperamide is 8 mg a day. For prescription use, the maximum approved dose is 16 mg a day.

Phase 3 Trial Fails for Treatment of ADHD Impulsive Aggression

In November Supernus announced that its novel treatment SPN-810 (molindone hydrochloride) for impulsive aggression in patients aged 6 to 11 years old with attention-deficit/hyperactivity disorder (ADHD) did not meet its primary endpoint. SPN-810 was previously marketed in the United States under the trade name Moban for treating schizophrenia, but at higher strengths and different dosage forms than those being studied for impulsive aggression in ADHD.

Youth who took 36 mg of SPN-810 daily for approximately six weeks experienced 58.6% fewer weekly impulsive aggression episodes by the end of the trial; however, this change was not significantly different from the change in youth taking placebo. The company said it would continue to analyze the results of the trial.

In the meantime, Supernus has stopped enrollment for a second phase 3 trial in patients aged 6 to 11, and its phase 3 trial in adolescents is on hold.

Fast Track Status Granted to PTSD Treatment

The FDA has granted fast track designation to BNC210 by Bionomics Limited for the treatment of posttraumatic stress disorder (PTSD) and other trauma-related and stressor-related disorders. The FDA Fast Track is a process designed to facilitate the development of drugs that treat serious conditions and fill an unmet medical need and expedite their review. BNC210 is a negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor.

Bionomics had previously reported that patients taking the liquid formulation of BNC210 as part of a phase 2 trial did not have significantly lower scores on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) after 12 weeks. The liquid had to be taken with food and varied in absorption, with the result that it provided lower exposure to the drug than needed. However, the trial showed how much BNC210 needs to be in the blood to achieve the primary endpoint.

Bionomics is now planning a phase 2 trial of a solid-dose formulation that the company says can achieve the necessary blood levels in people to significantly improve their PTSD symptoms.

Aducanumab Makers To Seek Approval for Alzheimer’s Drug

Aducanumab, an investigational drug for the treatment of mild cognitive impairment due to Alzheimer’s disease, appeared to be dead in the water last spring when Biogen and Eisai Co. Ltd. discontinued the phase 3 ENGAGE and EMERGE trials. The companies had decided to stop the trials after a futility analysis by an independent data monitoring committee indicated that aducanumab would most likely not meet the primary endpoints.

Biogen now plans to pursue regulatory approval for aducanumab after a new analysis of a larger dataset from the trials showed that the biologic met its primary endpoints. The new analysis was conducted by Biogen in consultation with the FDA and showed that patients with early Alzheimer’s disease who took aducanumab had less brain amyloid and cognitive decline than those taking placebo. Biogen plans to submit a Biologics License Application to the FDA in early 2020.

FDA Approves Fast-Acting Migraine Treatment

The FDA has approved Reyvow (lasmiditan) tablets for the acute treatment of migraine in adults. Reyvow, a serotonin 5-HT1F receptor agonist by Eli Lilly and Co., is indicated for patients who experience migraines with and without aura (visual and other sensory disturbances), but not for preventive treatment of migraine.

The approval was based in part on two randomized, double-blind, placebo-controlled trials involving 3,177 adult patients. A significantly greater percentage of patients who received Reyvow during a migraine attack reported that their pain and migraine symptoms, including nausea and light sensitivity, resolved within two hours of treatment compared with those who received placebo.

The most common side effects reported by patients included dizziness, fatigue, tingling or numbing sensations on the skin, sedation (sleepiness or drowsiness), nausea and/or vomiting, and muscle weakness.

Dulaglutide May Reduce Binge Eating in Patients With Type 2 Diabetes

Lilly’s type 2 diabetes medication Trulicity (dulaglutide) may reduce binge eating in patients with type 2 diabetes and binge eating disorder, according to data presented in September at the European Association for the Study of Diabetes 2019 Annual Meeting. Trulicity is a glucagon-like peptide-1 receptor agonist.

The study involved 60 patients younger than 65 years with type 2 diabetes and “intermediate severity” of binge eating (defined by presenters as 23.7 on the binge eating scale). Study participants received either Trulicity (subcutaneously, 1.5 mg/week) or the diabetes medication gliclazide (60 mg/day slow release) for 12 weeks.

Patients who took Trulicity reported a significantly greater reduction in binge eating severity than those who took gliclazide (-12.07 versus -0.47), the researchers reported. Those taking Trulicity also had greater reductions in BMI and weight. ■