MedCheck: Nalmefene Auto-Injector, Home Sleep Apnea Test, and More

The U.S. Food and Drug Administration (FDA) approved Zurnai (nalmefene hydrochloride) auto-injector by Purdue Pharma L.P. for the emergency treatment of known or suspected opioid overdose in people at least 12 years old, the agency announced in August. The auto-injector is pre-filled and delivers 1.5 mg of nalmefene in a single dose either subcutaneously or intramuscularly. It is available only by prescription.

The approval is based on safety and pharmacokinetic studies, as well as a study in healthy individuals who use opioids recreationally, to assess how quickly the product works. In that study, researchers induced respiratory depression via fentanyl in 24 opioid-experienced, non-opioid-dependent people. Respiratory depression reversal occurred between 2.5 and five minutes after administration, and full respiratory recovery occurred between five and 15 minutes after administration.

The most common adverse reactions are dizziness, nausea, headache, chills, vomiting, allodynia (feeling pain from actions that are not typically painful, such as lightly touching the skin), palpitations, tinnitus, ear discomfort, burning sensation, hot flush, irritability, feeling abnormal, and feeling hot.

In August, Amneal Pharmaceuticals Inc. announced that the FDA approved Crexont (carbidopa and levodopa, formerly known as IPX203) extended-release capsules for the treatment of Parkinson’s disease. Crexont combines immediate-release granules and extended-release pellets in one capsule.

In the Phase III RISE-PD trial, 506 patients who were at least 40 years old when they were diagnosed with Parkinson’s disease were randomized to receive either Crexont or immediate-release carbidopa/levodopa. All patients had motor fluctuations.

The primary endpoint was change from baseline in the daily amount of “Good On” time, defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia. At the twentieth week, those who took Crexont had an average of roughly half an hour more of “Good On” time compared with those who took immediate-release carbidopa/levodopa.

The FDA granted 510(k) clearance for the Sansa home sleep apnea wireless diagnostic patch, Huxley Medical Inc. announced in August. The clearance allows Huxley Medical to market the device, which will be available by prescription for use in either a clinical or home setting under the guidance of a health care professional. The chest-worn patch measures blood oxygen saturation, EKG-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position, and actigraphy (activity and rest cycles over time).

The clearance was granted based on the results of a trial in 533 patients with moderate to severe sleep-disordered breathing. The trial found that the device was able to detect sleep apnea with 88.2% sensitivity and 87.3% specificity, with results similar in populations of varying skin tones.

The shelf-life of Kloxxado (naloxone) 8 mg nasal spray has been extended from 24 to 36 months, Hikma Pharmaceuticals USA Inc. announced in August. The new 36-month dating began with products manufactured in March of this year.

Kloxxado has twice as much naloxone as Narcan and was approved by the FDA in 2021 for the reversal of opioid overdose. ■