In the CRL, the agency cited observations identified during inspection of a third-party manufacturer listed in the NDA. If approved, ABBV-951 would be the first subcutaneous delivery option of carbidopa/levodopa.

Although the data used predated 2019, istradefylline was associated with a statistically significant lower odds of the overall incidence of treatment-emergent adverse events than other adjunctive therapies for Parkinson disease.

StrivePD and Apple Watch continuously track motor symptoms, aiding neurologists in adjusting treatments for better patient outcomes.

In a large-scale analysis. 70% of patients with essential tremor and 70% of undiagnosed patients reported dissatisfaction with the therapeutic options available to treat their condition.

Pitolisant is the first and only drug in the class of antagonist/reverse agonists of the histamine H3 receptor for the treatment of patients with narcolepsy.

Here's some of what is coming soon to NeurologyLive® this week.

Approximately 83% of patients reported that they did not disclose to their provider that they experienced symptoms or had concerns about living with a movement disorder.

In recent analysis indicated that initiating apomorphine hydrochloride injection without antiemetic premedication was well-tolerated among patients with Parkinson disease.

An open-label phase 2b trial assessing ND0612 showed that the rate of treatment responders increased over a 12-month period among patients with Parkinson disease who experienced motor fluctuation.

Test your neurology knowledge with NeurologyLive®'s weekly quiz series, featuring questions on a variety of clinical and historical neurology topics. This week's topic is on Alzheimer disease/dementia.

Patients treated with at least 12.5 mg/day of oral prednisone for at least 3 months had an 88% reduction in the risk of relapse compared with those who did not receive this regimen.

The therapy is the first and only neonatal Fc receptor blocker approved for the treatment of CIDP, and will be available as a once-weekly, 30- to 90-second subcutaneous injection.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending June 21, 2024.

Neal K. Shah, CEO of CareYaya Health Technologies, discussed how sleep apnea and cognitive decline may be interrelated and disproportionately affecting minoritized populations.

The AAV vector-based gene therapy originally received FDA approval for treating ambulatory pediatric patients aged 4 to 5 years with Duchenne under the accelerated approval pathway.

Eric Herzog, PhD, a chronobiologist and professor of biology and neuroscience at Washington University, provided thoughts on a number of topics related to sleep during pregnancy and the significance of maintaining circadian rhythms.

A statistically significant dose-response correlation was observed, indicating that greater lifestyle changes led to better cognitive and functional outcomes in Alzheimer's patients.

A phase 3 trial showed that over time, Hyqvia is a safe and well-tolerated maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy.

The phase 3 trials investigating soticlestat for Dravet syndrome and Lennox-Gastaut syndrome (LGS) yielded mixed results on primary end points but showed promise in secondary outcomes.

CNM-Au8, an oral suspension of clean-surfaced, catalytically-active gold nanocrystals, resulted in prolonged survival and reductions in neurofilament light, a prominent biomarker of neuroaxonal damage.

ND0612, an investigational agent, had supportive data from the pivotal phase 3 BouNDless trial, a large-scale, phase 3 study of patients with Parkinson disease.

In recent news, Otsuka has discontinued the development of AVP-786 following results from phase 3 trial assessing the treatment in patients with agitation related to Alzheimer disease.

The director at the Foundation for the National Institutes of Health provided commentary on a recently launched partnership aimed at building a repository of ALS data to advance drug development for the disease.

A recent study showed a significant association between sleep apnea, additional sleep characteristics, and late-onset epilepsy in older adults, even after adjusting for comorbidities.

Marinus Pharmaceuticals reported that it will continue to analyze the full dataset and engage with the FDA to discuss the future of ganaxolone for treating refractory status epilepticus.