Med Check: Vyvanse, Levodopa/Carbidopa, Naloxone, and More

First Generics of Vyvanse Approved by FDA

The U.S. Food and Drug Administration (FDA) in August announced that it approved several first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder in patients 6 years and older and moderate to severe binge-eating disorder in adults.

Generic medications that are approved by the FDA provide the same clinical benefits and risks as their brand-name counterparts.

In the FDA’s notice announcing this approval, the agency stated: “The prescribing information for lisdexamfetamine dimesylate capsules and chewable tablets contains a boxed warning to inform health care providers and patients about the potential risk of abuse and dependence. ... Health care providers should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.”

Other risks of the medication include serious cardiovascular reactions, blood pressure and heart rate increases, and serotonin syndrome.

Levodopa/Carbidopa Combination Promising for Parkinson’s Disease

Mitsubishi Tanabe Pharma America Inc.’s ND0612 (continuous subcutaneous levodopa/carbidopa) may improve symptoms of Parkinson’s disease, the company announced in August.

In a phase 3 trial, 381 patients with Parkinson’s disease were randomized to receive either oral immediate-release levodopa/carbidopa or ND0612 for 12 weeks. Patients who received ND0612 had a mean of 1.72 hours of more “on” time (time without troublesome dyskinesia) compared with those who received oral immediate-release levodopa/carbidopa. Those who received ND0612 also had a reduction in “off” time (time with troublesome dyskinesia) and improved scores on the MDS-Unified Parkinson’s Disease Rating Scale Part II score (which assesses motor experiences of daily living), the Patient Global Impression of Change, and the Clinical Global Impression of Improvement scale.

Infusion site reactions were the most reported treatment-emergent adverse events, occurring in 57% of patients who received ND0612 and 43% of those who received oral immediate-release levodopa/carbidopa. Some infusion site reactions were more frequent in the ND0612 group compared with the oral immediate-release levodopa/carbidopa group, including hematoma, infection, erythema, pain, and infusion eschar.

OTC Naloxone Available

Padagis LLC has launched the first over-the-counter naloxone HCl nasal spray for the reversal of opioid overdose, the company announced in August. The nasal spray is available in a 4 mg dose, the same dose of active ingredient found in Narcan nasal spray.

The FDA approved Narcan for purchase without a prescription in March. Narcan is now also available over the counter.

Fasedienol Nasal Spray May Reduce Social Anxiety

A phase 3 trial of fasedienol nasal spray suggests it may help alleviate symptoms of social anxiety disorder in adults, Vistagen announced in August. Fasedienol is a first-in-class, rapid-onset investigational pherine nasal spray.

In the trial, 141 adults with social anxiety disorder were randomly assigned to receive fasedienol or placebo intranasally 20 minutes before a public-speaking task designed to induce stress. All patients had a baseline score on the Liebowitz Social Anxiety Scale of at least 70. The primary endpoint of the study was the difference in patient-reported Subjective Units of Distress Scale (SUDS) score during the public-speaking challenge.

SUDS scores were a mean of 5.8 points lower in patients who took fasedienol compared with those who took placebo. In addition, Clinical Global Impressions Improvement scores suggested that 37.7% of patients who took fasedienol responded to the treatment, compared with 21.4% who took placebo. ■