Blue Person Syndrome

The US Food and Drug Administration (FDA) issued a drug safety communication on April 26, 2013, alerting the medical community that ezogabine (Potiga™; GlaxoSmithKline, Research Triangle Park, North Carolina), one of the newest antiepileptic drugs, may cause blue-gray skin discoloration and retinal pigment changes.

Ezogabine

Ezogabine, formerly known as retigabine, received FDA approval as Potiga for adjunctive treatment of partial-onset seizures in adults on June 10, 2011. Ezogabine is a positive allosteric modulator of KCNQ2-5 potassium channels that inhibits high-frequency action potential firing, a unique mechanism of action for an antiepileptic drug.^[2] Ezogabine was co-developed by GlaxoSmithKline and Valeant Pharmaceuticals and marketed as Trobalt® in the European Union. An article^[3]about ezogabine that included a summary of 2 phase 3 clinical trials appeared in this column shortly after the drug received FDA approval

(fonts: medscape)

FDA Issues Warning About Antiseizure Drug Potiga

Neurologists and other physicians using the antiseizure drug (ezogabine (Potiga, Valeant Pharmaceuticals) as an adjunct treatment in patients with partial-onset epilepsy should be on the lookout for blue skin discoloration and retinal abnormalities and report these adverse effects should they occur.

The Food and Drug Administration (FDA) has issued a warning that ezogabine can cause pigment changes and eye abnormalities. According to a government press release, it's not known at this time whether these changes are reversible. The FDA said it is working with the manufacturer to gather and evaluate all available information to better understand these developments and will update the public when more information is available.

The FDA recommends that all patients taking ezogabine have a baseline eye examination and periodic eye examinations that should include visual acuity testing and dilated fundus photography. Periodic examinations may include fluorescein angiography, ocular coherence tomography, perimetry, and electroretinography.

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Novel Agent Safe, Effective for Parkinson's Psychosis

San Diego, California — A novel, first-in-class, nondopaminergic agent that selectively blocks serotonin 5-HT2A is safe and effective for the treatment of Parkinson's disease psychosis (PDP), new research suggests.

Confirming previously released topline results and reported byMedscape Medical News at that time, the phase 3 placebo-controlled trial showed that the selective nondopaminergic 5-HT2A receptor agonist pimavanserin was significantly better than placebo at reducing PDP.

American Academy of Neurology (AAN) 65th Annual Meeting. Emerging Science Session Abstract 004. Presented March 15, 2013.

Pseudobulbar Affect (PBA)

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization of a treatment for pseudobulbar affect (PBA) in adults (Nuedexta, Avanir Pharmaceuticals Inc).

The treatment, a combination of dextromethorphan hydrobromide and quinidine sulphate, is already approved for this indication by the United States Food and Drug Administration (FDA).

Ecco il link al prodotto:

https://www.nuedexta.com/

FDA Approves First Heptavalent Botulism Antitoxin

The US Food and Drug Administration (FDA) last Friday approved the first botulism antitoxin to neutralize all 7 known botulinum nerve toxin serotypes — valuable versatility for a drug in the nation's emergency medicine cabinet against a bioterrorist attack.

The heptavalent botulism antitoxin (BAT, Cangene) had been available on an investigational basis from the Centers for Disease Control and Prevention (CDC). Cangene began supplying doses of BAT to the US Strategic National Stockpile in 2007 under a $427 million contract with the Department of Health and Human Services, according to a company press release. The CDC will distribute the stockpiled antitoxin.

"This product approval meets an urgent unmet medical need for the treatment of sporadic cases of life-threatening botulism and provides a medical countermeasure should botulinum nerve toxins be used in a terrorism event," said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in a press release.

The FDA established the efficacy of the antitoxin in animal studies. Performing such studies in humans would not have been feasible or ethical, according to the agency.Derived from horse plasma, the heptavalent antitoxin is the only drug available for treating botulism in adults, and for botulism in infants caused by nerve toxins other than types A and B.

No FDA Approval Yet for Levadex, Inhaled Migraine Treatment

The US Food and Drug Administration (FDA) has declined approval for an orally inhaled formulation of dihydroergotamine (DHE; Levadex, Allergan Inc) for acute treatment of migraine in adults.

The hope for the new formulation of DHE, which is already available as an intravenous agent and as an intranasal treatment (Migranal, Valeant Pharmaceuticals), is to provide a rapid onset of action and sustained pain relief with fewer adverse effects compared with intravenous administration.

This FDA approval application was based on phase 3 findings from the multicenter, randomized, double-blind, placebo-controlled phase 3 trial, FREEDOM-301, reported previously by Medscape Medical News. The trial met all 4 primary endpoints of relief of pain, phonophobia, and photophobia and freedom from nausea at 2 hours. The study was funded by MAP Pharmaceuticals Inc, which developed the Tempo inhaler to deliver the drug, and was acquired by Allergan Inc earlier this year.

The drug showed rapid and sustained efficacy, was well tolerated with minimal adverse effects, and produced a low incidence of triptan-like sensations. It also appeared effective in patients generally thought to be treatment-resistant. The most common adverse event was medication aftertaste, reported in 6% of the treatment group but also in 2% of placebo-treated patients. There were no decreases in lung function

Subcutaneous immunoglobulin in responders to intravenous therapy with chronic inflammatory demyelinating polyradiculoneuropathy

Markvardsen JC et al.European Journal Of Neurology, 20: 5: 835-842

Background and purpose

We hypothesized that subcutaneous administration of immunoglobulins (SCIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is feasible, safe and superior to treatment with saline for the performance of muscle strength.

Methods

Thirty patients with motor involvement in maintenance therapy with intravenous immunoglobulin (IVIG) fulfilling the EFNS/PNS criteria for CIDP, aged 18–80 years, were randomized either to SCIG at a dose corresponding to their pre-study IVIG dose or to subcutaneous saline given twice or thrice weekly for 12 weeks at home. At the start and end of the trial as well as 2 weeks before (−2, 0, 10, 12 weeks), isokinetic strength performance of four predetermined and weakened muscle groups was measured. Also, an Overall Disability Sum Score (ODSS), 40-m-walking test (40-MWT), nine-hole-peg test, Neurological Impairment Score (NIS), Medical Research Council (MRC) score, grip strength, standardized electrophysiological recordings from three nerves, and plasma IgG levels were evaluated.

Results

SCIG treatment was well tolerated in all 14 patients. Six patients complained of mild side-effects at the injection site. In the SCIG group there was an increase of isokinetic muscle strength of 5.5 ± 9.5% (P < 0.05) as compared with a decline of 14.4 ± 20.3% (P < 0.05) in the placebo group; the difference between the two groups being significant (P < 0.01). ODSS, NIS, MRC, grip strength and 40-MWT improved following SCIG versus saline.

Conclusions

SCIG treatment in CIDP is feasible, safe and effective, and seems an attractive alternative to IVIG.