Launch of Migraine Patch Zecuity Delayed: NuPathe Inc.

nupathe-patch

 

NuPathe Delays The Launch Of Zecuity To Early 2014 (1)

The innovative neuroscience solutions company NuPathe Inc. has announced a delay in the launch of it’s product – a migraine patch that is worn directly on the skin of the upper arm, called Zecuity. The product that was expected to hit the market near the end of this year has now been shifted to early 2014. NuPathe had obtained FDA approval for the marketing of Zecuity earlier this year.

Zecuity is basically a drug delivery system. To be precise it is a sumatriptan iontophoretic trans-dermal system, i.e. it delivers sumatriptan via the skin route using the process of iontophoresis. Iontophoresis involves the delivering of a drug through the skin using low electrical current and so the Zecuity skin patch is embedded with two coin cell lithium batteries which regulate the quantity of current applied and sumatriptan delivered (2). So far, sumatriptan has been known to be delivered through the oral route as pills, injections or as spray via the nasal route. Zecuity is safe for the treatment of acute migraines on patients with or without aura.

Without going into details, the NuPathe CEO Armando Anido, “NuPathe has made substantial progress [toward] securing a partner to maximize the commercial potential of Zecuity. We believe that puts us in a good position to secure a commercial partner and while we have made progress on the partnership and manufacturing fronts, in order to extend our cash runway, we are limiting and delaying certain sales and marketing activities” (3)

However caution is to be exercised with the use of Zecuity if the migraine patient is already on Selective Serotonin Re-uptake Inhibitors (SSRIs), Selective Norepinephrine Inhibitors (SNRIs) or has previously existing conditions such as epilepsy, cardiovascular diseases (heart disease and stroke), diabetes or high cholesterol levels, pregnant or undergoing menopause. (4)

SOURCES

  1. Image Credits: ZECUITY Electronic Drug Patch for Acute Migraines Approved in U.S.Medgadget.com; November 2013; http://www.medgadget.com/2013/01/zecuity-electronic-drug-patch-for-acute-migraines-approved-in-u-s.html
  2. Zecuity; RxList.com; Web November 2013; http://www.rxlist.com/zecuity-drug.htm
  3. NuPathe delays launch of migraine patch; Healthcare Inc. Philadelphia – BizJournal.com; Web November 2013; http://www.bizjournals.com/philadelphia/blog/health-care/2013/11/nupathe-delays-launch-of-migraine-patch.html
  4. Zecuity; zecuity.com; Web November 2013; http://www.zecuity.com/

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Migraining Women Likely To Develop Dementia: Study

Dementia Risk For Migraineurs

 

Migraineurs With Aura Are 48% More Likely To Develop Dementia In Later Life (1)

As if the sustained pounding, debilitating pain, the flurry of traumatic symptoms and ineffective medicines were not enough for migraineurs, studies are now showing that persons who suffer migraines with visual and other aura are 48% more likely to develop dementia as they begin to age than their healthier counterparts! (2)

In part this could be explained by the presence of white matter lesions that the brains of migraineurs are often seemed to have when scanned using an MRI (Magnetic Resonance Imaging).

We know that white matter of the brain consists of nerve fibres (axons) and are surrounded by fat called myelin (3). The main function of the white matter is to transmit signals from one region of the cerebrum to another and between the cerebrum and lower brain centres. Lesions in the white matter interfere with signal transmissions. Damage to this white matter is a common significant factor observed in all those suffering from dementia.

Earlier control tests and those conducted at the Changhua Christian Hospital, Taiwan has already shown that migraineurs are at an exponential risk of diabetes and of developing hypertension, depression and cardiovascular diseases.

However, other studies have shown that the mental status of women with a history of migraine was no different from other women’s, so more research is needed.

SOURCES

  1. Image Credits: Dementia Disease And A Loss Of Brain Function And Memories As Al by David Castillo Dominici: FreeDigitalPhotos.net; Web November 2013; http://www.freedigitalphotos.net/images/dementia-disease-and-a-loss-of-brain-function-and-memories-as-al-photo-p173821
  2. Migraine may be linked to dementia; IOL Lifestyle; Web November 2013; http://www.iol.co.za/lifestyle/migraine-may-be-linked-to-dementia-1.1608597#.UoowF9JmiSo
  3. White matter of the brain; MedlinePlus; Web November 2013; http://www.nlm.nih.gov/medlineplus/ency/article/002344.htm

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Disrupted Default Mode Network Seen In Migraineurs W/o Aura: Study

Neural Netwoork

The Default Mode Network Shows Functional Disruptions For Migraineurs W/o Aura (1)

A recent study published in The Journal of Headache and Pain spoke of disrupted default mode network in migraineurs. The study used specialized imaging device, the RS-fMRI or the Resting State functional MRI to show the disrupted network in pain conditions including migraines.

The research departments of five institutes were involved in this groundbreaking study – Department of Neurology, Second University of Naples, Institute for Diagnosis and Care “Hermitage Capodimonte”, Neuro-radiology Service, Second University of Naples, Department of Cognitive Neuroscience, Maastricht University, Maastricht, The Netherlands, and Department of Medicine and Surgery, University of Salerno.

A default mode network or DMN is the arrangement of connections of different brain regions which are active when a person is not focussed on something yet is in wakeful rest state. At such a state, the default mode network takes over and it is characterized by coherent neuronal oscillations at a rate lower than 0.1 Hz (2). However, when the mind is focussed on to something like task completion activities, the DMN is automatically de-activated and another network known as the Task Positive Network or TPN is activated.

The study was aimed at finding the DMN functional connectivity in migraineurs without aura and see if it was clinically relevant. Two groups were used in the study population – 20 patients with migraines without aura and 20 gender and age-matched healthy controls were studied. The imaging and tracking tools used were Brain Voyager QX. Voxel-based morphometry was used to assess whether between-group differences in DMN functional connectivity were related to structural differences.

The study exhibited that there was a significant reduction in the connectivity at the prefrontal and temporal regions of the default network (DMN) for the migraineurs without aura. However, there was no correlation of these findings with the fact if the migraineurs had any structural abnormalities or clinical and neuropsychological features.

As per the research correspondent Alessandro Tessitore, “We hypothesize that a DMN dysfunction may be related to behavioural processes such as a maladaptive response to stress which seems to characterize patients with migraine.” (3)

To view details of this study, you may access the Springer’s Open Access pdf file: http://www.thejournalofheadacheandpain.com/content/pdf/1129-2377-14-89.pdf

SOURCES

  1.  Image Credits: Neuron by Renjith Krishnan; FreeDigitalPhotos,net; Web November 2013; http://www.freedigitalphotos.net/images/Human_body_g281-Neuron_p125335.html
  2. Default Mode Network; Wikipedia; Web November 2013; http://en.wikipedia.org/wiki/Default_mode_network
  3. Disrupted default mode network connectivity in migraine without aura; 7thSpaceInteractive; Web November 2013; http://7thspace.com/headlines/446815/disrupted_default_mode_network_connectivity_in_migraine_without_aura.html

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Health Canada Recalls GSK’s Imitrex

Imitrex syringe

Potentially Infected Needles In Injection Form Of Imitrex (1)

Pharmaceutical giant GlaxoSmithKline (GSK) has recalled lot number C637078 and C632842 of it’s migraine drug Imitrex. The recalled drug is not of the tablet or nasal spray form but it’s injection form which comes in syringes pre-filled with the sumatriptan solution along with sterile needles that are to be injected.

The decision to recall has been made in discussions with Health Canada. Health Canada is Canada’s federal department that helps its citizens maintain, regulate and improve their health.

Fears have been allayed with clarifications from the regulatory body that it is not the quality of the drug that was suspect but that the needles were protruding past their plastic shields thus compromising their sterility thus posing potential risk of infection to consumers. (2)

SOURCES

  1. Image Credit: Health Warehouse; Disposable Syringes 5/8” Needle; Web November 2013; http://www.healthwarehouse.com/needles-syringes/disposable-syringes/needle-length/5-8-needle-length
  2. Migraine medication Imitrex recalled by Health Canada; CBC News, Calgary; Web November 2013; http://www.cbc.ca/news/canada/calgary/migraine-medication-imitrex-recalled-by-health-canada-1.2350615

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