FDA Approves Auotinjector for Status Epilepticus, Penumbra System Removes Clots in Ischemic Stroke, Tobacco Use Correlated With Cognitive Decline


Neurology News Network for the week ending September 3, 2022. [WATCH TIME: 4 minutes]

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

The FDA has given the green light to Rafa Laboratories for its 10-mg midazolam autoinjector for the treatment of status epilepticus in adults.1 It is the first autoinjectable product to be approved by the FDA, joining other rescue treatments with different routes of administration. According to the American Epilepsy Society treatment guidelines, midazolam intramuscular injection is a first-line therapy for status epilepticus. Similarly, Neurocritical Care Society guidelines state that irreversible brain damage or death may occur if seizures are not stopped within 60 minutes of onset.3 The midazolam autoinjector is administered into the thigh, and can be done through clothing, without requiring an intravenous line, according to Rafa. The Rafa autoinjector was developed in partnership with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), with additional support from the Chemical and Biological Defense Program. Previously, the government entity collaborated with Rafa on its Atropine autoinjector.

Presented at the 2022 World Federation of Interventional and Therapeutic Neuroradiology, new data from the INSIGHT Registry showed that the use of Penumbra’s RED reperfusion catheters were successful in removing all clot types in patients with acute ischemic stroke. Additionally, findings from a subanalysis of the COMPLETE study (NCT03464565) revealed effectiveness of the Penumbra System to treat tandem lesions in these patients, as well as those considered to be in the later window of treatment.The Penumbra System is a fully integrated system engineered for effective clot removal and is intended for patients with acute ischemic stroke secondary to intracranial large vessel occlusions. In a cohort of 161 patients with acute ischemic stroke from the INSIGHT Registry, treatment with Penumbra’s latest reperfusion catheters resulted in successful first-pass revascularization, indicated by modified Thrombolysis in Cerebral Infarction (mTICI) scores between 2b and 3, which occurred in 68.9% of patients. In total, site reported findings showed that 97.0% of patients had successful revascularization after final angiogram. Final mTICI scores of at least 2b-3 were reported in 98.1% of patients with firm-red clots and in 100% of patients with other clot types.

Data from a large-scale study of more than 10,000 children aged 9 to 10, findings showed that initiating tobacco use was associated with inferior cognitive performance and reduced brain structure with sustained effects at 2-year follow-up.A total of 11,729 children from 21 US sites enrolled in the Adolescent Brain Cognitive Development (ABCD) study were included wave 1 from October 2016 to October 2018, and followed up 2 years later from August 2018 to January 2021. Participants were asked to complete a survey about their tobacco use, and products such as electronic cigarettes (e-cigarettes), cigarettes, cigars, smokeless tobacco, hookah, pipes, and nicotine replacement. There were 116 children who reported ever using tobacco products, deemed the ever user group. This group exhibited lower scores on the Picture Vocabulary Test, lower crystalized cognition composite scores, and total cognition composite scores. At the 2-year follow-up, tobacco ever users had lower cortical volume in frontal, parietal, and temporal lobes than nonusers.

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