Med Check: Opioid Blister Packaging; Vraylar; Warning For Insomnia Drugs; Disposal of Opioids; Naloxone Nasal Spray; NeuroSigma’s ADHD Device

FDA Requests Comments on Opioid Blister Packaging

The Food and Drug Administration (FDA) has asked for public feedback on the potential public health impact of requiring that certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use-blister packaging. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act allows the FDA to require special packaging for opioids and other drugs that pose a risk of abuse or overdose.

The FDA has also requested feedback on which specific opioid products are good candidates for blister packaging and the number of pills that should be included in blister packaging configurations. In addition, commenters are invited to provide feedback on the potential challenges of the proposed requirement.

The comment period ends on July 30. Those wishing to submit a comment may do so by visiting the public docket published in the May 31 Federal Register, which is posted here.

Vraylar Approved For Expanded Use to Treat Bipolar Depression

Vraylar (cariprazine) has received FDA approval for expanded use in treating depressive episodes associated with bipolar I disorder in adults, Allergan plc and Gedeon Richter Plc. announced in May.

In three clinical trials, participants who took cariprazine demonstrated greater improvements on the Montgomery-Åsberg Depression Rating scale from baseline to week six than those who took placebo. In all three studies, the 1.5 mg dose demonstrated statistical significance over placebo. In a third study, the 3 mg dose demonstrated statistical significance over placebo. Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.

Vraylar is also approved for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder and for the treatment of adults with schizophrenia.

FDA Adds Boxed Warning For Certain Insomnia Drugs

In April the FDA announced that a black-box warning must be added to the prescribing information and patient medication guides for Lunesta (eszopicline); Sonata (zaleplon); and Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist (zolpidem).

The FDA noted in a Drug Safety Communication that rare but serious injuries have occurred with these medications because of complex sleep behaviors such as sleepwalking, sleep driving, and engaging in other activities while not fully awake. These behaviors have occurred in patients with or without a history of them, and they have occurred at the lowest recommended doses—even after just one dose. The FDA also required that a contraindication be added to the medications’ labeling for patients who have already had an episode of any of these complex sleep behaviors. Patients should immediately stop taking these medications if they experience any of these behaviors.

Injuries resulting from drug-related complex sleep behaviors are rare but can be life-threatening. The FDA identified 66 cases of injuries from complex sleep behaviors, including accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures and loss of limb, carbon monoxide poisoning, drowning, hypothermia, car crashes, and self-inflicted gunshot wounds.

‘Remove the Risk’ Seeks To Improve Disposal of Unused Opioids

As many as 90% of patients who are prescribed opioid medications do not finish taking their medications and many do not dispose of them properly, leaving millions of leftover opioids in homes, where they are accessible to children who may take them by accident and to others who may misuse them intentionally.

To combat the risks of keeping unused opioids in the home, the FDA launched a new awareness campaign called “Remove the Risk.” The campaign seeks to educate Americans about the risks of keeping unused opioids and the importance of properly removing and disposing of them. It targets women aged 35 to 64 years because they are most likely to oversee health care in their households.

The campaign includes a toolkit of materials in English and Spanish and includes radio, television, and print public service announcements, fact sheets, social media graphics and posts, and website badges. The toolkit is posted here.

FDA OKs First Generic Naloxone Nasal Spray

Teva Pharmaceutical Industries Ltd. has won FDA approval for a generic version of its Narcan (naloxone hydrochloride) nasal spray to stop or reverse the effects of an opioid overdose. Generic naloxone nasal spray is approved for use in children or adults in a community setting by individuals without medical training—including family, friends, and caregivers of people who take opioids—and does not require assembly.

According to an FDA press release, the spray delivers a consistent measured dose when used as directed. It is sprayed into one nostril while the patient is lying on his or her back and can be administered again if necessary.

NeuroSigma’s ADHD Device Wins FDA Approval

The FDA has approved the first medical device for the treatment of attention-deficit/hyperactivity disorder (ADHD). The Monarch external Trigeminal Nerve Stimulation (eTNS) System by NeuroSigma is indicated for children aged 7 to 12 years who are not taking prescription ADHD medications. It is available by prescription only.

While the child sleeps, the device delivers low-level, electrical pulses to the child’s trigeminal nerve via wires and a small patch adhered to the child’s forehead. The exact mechanism of eTNS is not yet known, but neuroimaging studies have shown that the trigeminal nerve connects to brain regions that are important in regulating attention, emotion, and behavior.

The efficacy of the Monarch system was shown in a clinical trial of 62 children with ADHD. The participants randomly received either eTNS or sham nerve stimulation nightly for four weeks. At the study’s completion, the children using the eTNS device had a statistically significant improvement in their ADHD symptoms compared with the sham group, as measured with the clinician-administered ADHD Rating Scale. The device was well tolerated; the most common side effects observed with eTNS were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. ■