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.

AAN Issues Guideline on Parenchymal Neurocysticercosis

sono disponibili nella casella condivisa come anche gli e-books le nuove linee guida AAN per la neurocisticercosi parenchimale, apparse su Neurology 

cari saluti

FDA clears clinical trial of Gilenya in ALS

The ALS Therapy Development Institute (ALS TDI) has received FDA approval to conduct a Phase 2a clinical trial of TDI-132 (fingolimod, Gilenya) for the treatment of amyotrophic lateral sclerosis (ALS).

Fingolimod is currently being marketed by Novartis as Gilenya to treat some forms of multiple sclerosis. The trial will determine the safety and tolerability of TDI-132/Gilenya in people with ALS.

ALS TDI, a non-profit biotech, is the sole funding sponsor of this clinical trial, thanks to the support it received from the ALS community. Current enrollment sites include Massachusetts General Hospital in Boston; University of California, Irvine in Orange; Georgia Health Sciences University in Augusta; and Methodist Neurological Institute in Houston.

“It was exciting to see how expeditious the FDA reviewed our application to test Gilenya in ALS patients,” said Steve Perrin, CEO and CSO, of ALS TDI. “We are eager to start enrolling patients in the clinical trial of TDI-132 and take this important step toward understanding whether or not Gilenya is a potential treatment for ALS.”

The Muscular Dystrophy Association’s “Augie’s Quest,” has contributed in funding the research leading to the advancement of the ALS clinical trial.

ALS TDI researchers first began preclinical testing of TDI-132 in 2011 for its ability to block certain immune cells from entering the brain and spinal cord, where they can cause activities that result in damage to motor neurons. The institute has confirmed that TDI-132 significantly reduces the circulation of these immune cells through the bloodstream, resulting in fewer of them infiltrating into the central nervous system. Further experiments at ALS TDI showed treatment with TDI-132 resulted in positive outcome based on several disease measures in preclinical studies.

Linee guida sulla prevenzione farmacologica dell'emicrania episodica nell'adulto

ciao a tutti, questa settimana proponiamo nuove linee guida, disponibili in casella condivisa. 

In particolare sono uscite su Neurology le linee guida per il trattamento farmacologico preventivo dell' emicrania nell'adulto. 

Le segnaliamo all'attenzione

Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society.

Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society.

Neurology. 2012 Apr 24;78(17):1337-45.

buona serata a tutti