Med Check: OTC Gel; Hetlioz; Ecopipam for Tourette’s Syndrome; Wakix for Daytime Sleepiness; Nourianz for Parkinson’s Disease

OTC Gel Now Available To Aid Pill Swallowing

Phasix—a gel designed to help patients older than two years swallow pills, capsules, and powders—became available over the counter in August.

Users place their medication on a spoon and cover it with a teaspoon of the gel. The product adheres to the medication from the mouth to the stomach. It works by moistening the mucous membranes in the mouth and throat cavity, so the medication does not get stuck on the way to the stomach. Once in the stomach, the gel breaks away from the surface of the medication so the drug can be digested, according to Arkray USA, the maker of the gel. Phasix does not affect the absorption rate of the drug, the company says.

FDA Rejects Hetlioz for Treating Jet Lag

In August the Food and Drug Administration (FDA) rejected Vanda Pharmaceuticals’ Hetlioz (tasimelteon) to treat jet lag. Hetlioz, a melatonin receptor agonist, is approved to treat non-24-hour sleep-wake disorder.

As part of the supplemental New Drug Application for Hetlioz, the company submitted data from a study of 25 patients who flew from the United States to London. In the study, those who took Hetlioz slept roughly three hours longer than those who took placebo. According to a statement issued by Vanda, the FDA asserted that the results “are of unclear clinical significance.”

Vanda is currently testing Hetlioz for treating delayed sleep phase disorder; pediatric non-24-hour sleep-wake disorder; and Smith-Magenis syndrome, a developmental disorder that is characterized in part by sleep disturbances.

Ecopipam Receives FDA Fast Track Designation for Tourette’s Syndrome

Ecopipam, an investigational therapy for pediatric patients with Tourette’s syndrome, received a “fast track” designation from the FDA in August. 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.

Ecopipam, manufactured by Emalex Biosciences Inc., is a first-in-class therapy that selectively blocks the actions of the neurotransmitter dopamine at a different receptor than approved therapies for Tourette’s syndrome.

The most common adverse events reported by patients taking ecopipam included sedation, insomnia, nausea, and vomiting. Emalex recently began enrolling children and adolescent patients ages 6 to 18 years for a phase 2b, double-blind clinical study of ecopipam, according to the company.

FDA Approves Wakix for Daytime Sleepiness Caused by Narcolepsy

In August the FDA approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness in adult patients with narcolepsy, Harmony Biosciences announced. Wakix is a selective histamine 3 receptor agonist–inverse agonist that works to increase the synthesis and release of histamine. It is a first-in-class oral medication that is administered once a day in the morning.

In two multicenter, randomized, double-blind, placebo-controlled studies, 261 patients with narcolepsy who took Wakix for eight weeks experienced a statistically significant improvement in excessive daytime sleepiness compared with those taking placebo, as measured by the Epworth Sleepiness Scale score. The most common adverse reactions reported by patients taking Wakix were insomnia (6%), nausea (6%), and anxiety (5%).

Wakix will be available in the United States later this year, the company said in a statement.

Nourianz Approved as Add-On Therapy for Parkinson’s Disease

Nourianz (istradefylline)—a selective adenosine A2A receptor antagonist—has received FDA approval as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who are experiencing “off” episodes. An “off” episode is an increase in Parkinson’s symptoms such as tremor or difficulty thinking when a patient’s medications are not working well.

Nourianz was studied in four 12-week, placebo-controlled trials totaling 1,143 participants with Parkinson’s disease who were already being treated with levodopa/carbidopa and who were experiencing an average of roughly six hours of “off” time a day. Those who took either 20 mg or 40 mg of Nourianz daily experienced a statistically significant decrease from baseline in daily “off” time compared with those who took placebo.

The most common adverse reactions in those who took Nourianz were involuntary movements, dizziness, constipation, nausea, hallucination, and insomnia. The maker of Nourianz is Kyowa Kirin. ■