Defective Nerve Insulation In Migraineurs: Study

ID-100122308

Myelin Sheath & Cellular Elements Over Axons of Nerve Cells Are Patchy Or Missing In Migraineurs (1)

A study conducted by a team of researchers from three different departments at Case Western School of Medicine, clearly exhibits that certain changes at the cellular-level of the nerve structure of migraineurs leads to migraines in many patients. This in turn brings about functional changes of the nerves and further contributes to painful migraine episodes.

The findings of the study were published in the November issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons. You can read the report by clicking on the link below (2)

Myelin is an electricity insulating material that forms a layer/sheath which surrounds the axon of a nerve cell/neuron. The detailed study of miniscule specimens of the trigeminal nerves of migraineurs showed that there were abnormalities in the myelin sheath that served as insulation around nerve fibres in the trigeminal nerves.

Another group of patients that had been evaluated and found eligible and thus had opted for plastic surgery as a route to treat their migraine was also studied. They had all undergone the forehead lift procedure, which involved removal of some muscle and vessel tissue surrounding the cranial nerves.

The nerve fiber samples of all these patients were studied and compared for proteomic analysis. Electron microscopy techniques were used for the process of evaluating the presence and functioning of different proteins in the nerve fiber obtained from the patient’s trigeminal nerves. It was found that migraining patients without the surgery had missing or defective myelin sheaths over their nerve cells compared to those that had opted for the surgery.

As per surgeon Bahman Guyuron, MD, of Case Western Reserve University, “If the insulation becomes cracked or damaged by conditions in the environment, that’s going to affect the cable’s ability to perform its normal function. In a similar way, damage to the myelin sheath may make the nerves more prone to irritation by the dynamic structure surrounding them, such as muscle and blood vessels, potentially triggering migraine attacks.” (3)

Another key observation made was that the placement and organization of cellular elements in the nerve fibers was tight and uniform for the group that undergone surgery to treat migraines whereas the migraining group was found to have a discontinuous and patchy distribution of the cellular elements in their nerve fibers.

This brings to light the criticality of the peripheral nerves in triggering complex events in a migraine attack that eventually involves our central nervous system. Co-authors of this study add, “These findings may also lead to other opportunities to treat patients with migraine headaches non-invasively, or with less invasive procedures that repair the defective myelin around nerves, lending additional protection for the nerves.”

SOURCES

  1. Image Credit: Neurons by Dreams Design; Freedigitialphotos.net; Web November 2014; http://www.freedigitalphotos.net/images/Human_body_g281-Neuron_p122308.html
  2. Excerpt of the study may be read at: Electron Microscopic and Proteomic Comparison of Terminal Branches of the Trigeminal Nerve in Patients with and without Migraine Headaches; Journal of The American Society of Plastic Surgeons; Web November 2014; http://journals.lww.com/plasreconsurg/pages/articleviewer.aspx?year=2014&issue=11000&article=00036&type=abstract
  3. Migraine Linked To Defective ‘Insulation’ Around Nerve Fibers, Suggests Study; Sciencedaily.com; Web November 2014; http://www.sciencedaily.com/releases/2014/11/141103113557.htm

 Copyrights apply to this blog. Please refer copyright permissions.

Peak Bio-availability in 2-3 Minutes: Aegis Awarded 3rd Patent for Intravail(R)

Aegis Therapeutics LLC

Aegis’ Non-Invasive Drug Delivery System For Migraines (1)

Aegis Therapeutics LLC, the developers of drug delivery and drug formulation technologies has announced that it has received it’s 3rd patent for fast acting formulations of triptans, a widely used class of drugs including Sumatriptan, Zolmitriptan, Naratriptan, Rizatriptan, Eletriptan, Almotriptan and Frovatriptan. The total triptan class of drugs has a market of over $3 billion of which Sumatriptan alone accounts for $2 billion.

Trials on humans have demonstrated that the now patented Intravail® formulation of sumatriptan is bioavailable in 2-3 minutes of administration.  This is a 20-30 times faster achievement of therapeutic drug levels than what is currently marketed non-invasive/non-injectable sumatriptan products. (2)

The most common triptan formulations currently available commercially – the oral tablet and the nasal spray reach peak blood level concentration of the drug in 60-120 minutes – many times slower than Intravail® formulation of sumatriptan and thus delaying onset of pain relief.

The new technology – Intravail® formulation of sumatriptan is widely applicable to other small molecule as well as biotherapeutic drugs that step up

The enabling Aegis Intravail formulation technology is broadly applicable to a wide range of small molecule and biotherapeutic drugs to increase noninvasive bioavailability by the oral, nasal, buccal, and sublingual routes especially in those cases where speed is important to the patient. Acute symptoms and A&E cases with severe pain, nausea, emesis, convulsive disorders, spasticity is expected to be greatly helped by the new Intravail® formulation of sumatriptan by Aegis Therapeutic LLC.

SOURCE:

  1. Image credits: Aegis Therapeutics LLC; Web August 2013; http://aegisthera.com/
  2. Aegis Awarded 3rd Patent for Fast Acting Migraine Nasal Spray Treatment; Aegis Therapeutics LLC; Web August 2013; http://aegisthera.com/aegis-awarded-3rd-patent-for-fast-acting-migraine-nasal-spray-treatment/

Copyrights apply on this blog. Please refer copyright permissions.

FDA Grants Approval To Rizatriptan Benzoate ODT For Acute Migraine Treatment

Migraine Blog Rizatriptan ODT

Rizatriptan Benzoate ODT approved by FDA and launched in the market.  Image is not of said drug (1)

Pharmaceutical company Breckenridge’s drug Rizatriptan Benzoate has been given the green flag for immediate launch by the U.S Food and Drug Administration. The drug comes in the form of orally disintegrating tablet (ODT). It is available commercially in packs of potency/dosage 5 mg and 10 mg.

Breckenridge’s drug Rizatriptan Benzoate ODT is manufactured and supplied by Natco Pharma Limited. Just like Merck & Co. Inc’s Maxalt MLT, Rizatriptan Benzoate ODT is a prescription drug used in the management and treatment of acute migraine.

The FDA granted final ‘go ahead’ for the Abbreviated New Drug Application (ANDA) for Rizatriptan Benzoate ODT some nine months prior to expiration of the pediatric-exclusivity period for the challenged Orange Book patent (April 1, 2014).

‘Breckenridge’s patent challenge regarding Rizatriptan Benzoate Orally Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago. Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.’ (2)

SOURCES:

  1. Image Credit: FreeDigitalPhotos.net; Yellow Tablet; Image by rakratchada torsap; Web July 2013; http://www.freedigitalphotos.net/images/agree-terms.php?id=10096441
  2. Breckenridge Pharmaceutical, Inc. Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets): BioSpace.com; Web July 2013;  http://www.biospace.com/news_story.aspx?StoryID=301892&full=1

Copyrights apply to this blog. Please refer copyright permissions.

New Guidelines from American Academy of Neurology On Reduction of Migraine Frequency

New guidelines or strategy if you will, have been chalked out and released by scientists at the American Academy of Neurology in conjunction with the American Headache Society on the approach migraineurs should take to reduce the frequency of their attacks. These guidelines have been released just this week and basically are a little different from the previous guidelines in terms that they reduce the ranking of certain migraine drugs (such as Verapamil and Gabapentin) which were highly recommended in the last guidelines due to evidence gathered against them. In addition, the new guidelines are based on evidence-based research on a larger population than were done for the last set of guidelines covering various demographics – gender, races etc. (1)

Want Fewer Migraine Attacks? Follow a Preventative Regimen Everyday (2)

As per the neurologists, almost 38% of all migraineurs should follow a preventative strategy to reduce the number of their migraine episodes. But only a third of that percentage followed a daily preventative regimen with the rest of them only resorting to band aid approaches and tackling the pain once they are in the throes of a migraine attack or are expecting one within a few hours. The approaches they often took were such as were not proven effective in scientific testing before.

According to Mark Green, MD, director of the Headache Center at Mount Sinai School of Medicine, in New York, “What the guidelines do is pinpoint first-line treatments based on evidence and effectiveness.  If these guidelines are used widely, we will be able to up the odds of reducing headaches by 50 percent. Moreover, the stakes may be high if we undertreat migraines. Evidence is building to suggest that if we allow migraines to progress, the frequency of attacks may increase, and they may also become harder to treat” (3)

Here’s a quick look at what the evidence-based preventative guidelines suggests to migraineurs:

  1. First line prescription drugs must be taken on a daily basis to bring down the number and intensity of the attacks.
  2. Effective For Prevention: Anti-seizure medications Divalproex sodium, Sodium valproate, Topiramate, Metoprolol, Propranol, Tumolol.
  3. Effective Herbal Preparations: Butterbur / Petasites.
  4. Probably Effective: Nonsteroidal anti-inflammatory drugs or NSAIDS such as Fenoprofen, Ibuprofen, Ketoprofen, Naproxen, Naproxen Sodium, Subcutaneous histamine, Complementary treatments, Magnesium, Riboflavin, Feverfew.
  5. Found Not Effective: Anti-seizure drug lamotrigine was not effective in preventing migraine.

SOURCES:

  1. New Guidelines Assert That Daily Preventive Therapies Significantly Reduce Migraines; Newswise; April 2012; http://www.newswise.com/articles/view/588495/?sc=rsmn&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+NewswiseMednews+%28Newswise%3A+MedNews%29
  2. Image by Ambro; Freedigitalphotos.net; April 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=1499
  3. New Guidelines: Treatments Can Help Prevent Migraine; American Academy of Neurology (AAN); April 2012; http://www.aan.com/press/index.cfm?fuseaction=release.view&release=1062

Video of the 2012 AAN Conference may be accessed at:

  1. 2012 AAN Press Conference: New Guidelines on Preventing Migraine Headache; YouTube.com; April 2012; http://www.youtube.com/watch?v=LoKPwq9JcKE&feature=g-upl&context=G2423319AUAAAAAAAAAA

Copyrights apply on this blog. Please refer copyright permissions.

Brain Freeze and Migraines: A Shared Mechanism At Play

Spoon in a large dollop of ice cream after you enter the house on a warm summer day and you know you are in trouble. The brain freeze will make you repent the haste almost immediately. Same with guzzling down a chilled soda. The sensation on the upper palate almost stops you in your tracks in a very uncomfortable way. Turns out, the mechanism involved in brain freeze is also at play during any migraine episode. (1)

Change in Brain’s Blood Flow Similar in Brain Freeze and a Migraine (2)

It is believed a brain freeze is an experience brought on by other experiences that are interpreted by the brain as traumatic and are often suffered by soldiers who have been close to explosions or have had combat injuries. One link between the brain freeze and the events in the onslaught of a migraine is the way there occurs a change in the blood flow of the brain.

Researchers at the Department of Veterans Affairs New Jersey Health Care System, the National University of Ireland Galway, Harvard Medical School and the the War Related Illness and Injury Study Center of the Veterans Affairs New Jersey Health Care System have observed in the experiments conducted in their study that sudden headache seems to be triggered by an abrupt increase in blood flow in the anterior cerebral artery and disappears when this artery constricts.

In the study the researchers observed 13 healthy adults whose cerebral blood flow was monitored using transcranial Doppler as they sipped ice water with a straw on their upper palate. This was done in order to have an onset of brain freeze. Next their cranial blood flow was noted using the same tool when they were made to sip water of room temperature in the same way. The volunteers were made to signal the onset and the dissipation of the brain freeze. The observations showed that one particular artery, called the anterior cerebral artery, dilated rapidly and flooded the brain with blood in conjunction to when the volunteers felt pain. Soon after this dilation occurred, the same vessel constricted as the volunteers’ pain receded.

As per the study lead Jorge Serrador of Harvard Medical School, “The brain is one of the relatively important organs in the body, and it needs to be working all the time. It’s fairly sensitive to temperature, so vasodilation might be moving warm blood inside tissue to make sure the brain stays warm. But the brain is a closed structure, so the sudden influx of blood could raise pressure and induce pain. The following vasoconstriction may be a way to bring pressure down in the brain before it reaches dangerous levels.” (3)

Serrador has pointed that similar changes in blood flow is noticeable in those who have migraines during a migraine attack or in those with post-traumatic headaches. This provides avenues for pharmaceutical companies to work on a drug that targets on areas based on the finding of this study, thus bringing about a change in the course of migraines and certain headache types.

SOURCES:

  1. Changes in Brain’s Blood Flow Could Cause ‘Brain Freeze’; Science Daily News; April 2012; http://www.sciencedaily.com/releases/2012/04/120422231742.htm
  2. Image by Victor Habbick; Freedigitalphotos.net; April 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=4036
  3. Changes in Brain’s Blood Flow Could Cause ‘Brain Freeze’; American Physiological Society – Onsite Newsroom; April 2012; http://www.the-aps.org/mm/hp/Audiences/Public-Press/For-the-Press/releases/12/15.html

 

Copyrights apply on this blog. Please refer copyright permissions.

Cambia Approved For Migraines In Canada

Health Canada has given a notice of compliance/approval to Stellar Pharmaceuticals’ generic drug Cambia. Cambia is used for the treatment of acute migraines in adults with or without aura. The chemical composition of this oral solution comprises of diclofenac potassium. Cambia is actually manufactured by Tribute Pharmaceuticals, a wholly owned subsidiary of Stellar Pharmaceuticals. (1)

Cambia (R) – Diclofenac Potassium Approved In Canada For Migraineurs(2)

This is a relief to the Canadian migraineurs as the generic drug is affordable. In Canada Cambia will be marketed exclusively by Nautilus Neurosciences. Oral tablets of diclofenac potassium have been available to the U.S patients since May 2010 after FDA approval. Diclofenac Potassium is a non-steroidal anti-inflammatory drug (NSAID) and a benzeneacetic acid derivative.

Cambia and other brands of diclofenac potassium are contraindicated for use in persons with cardiovascular condition, peri-operative pain in the setting of coronary artery bypass graft and those with gastrointestinal sensitivity and conditions.

According to Rob Harris, President and CEO of Stellar Pharmaceuticals, “We feel that CAMBIA(R) represents a logical first line prescription treatment choice for acute migraine, especially when over-the-counter medicines that offer some relief with milder forms of migraine pain fail, and where side effects or tolerability issues with the triptan class of drugs becomes a concern. With CAMBIA(R), Canadian physicians now have a new treatment option with comparable efficacy to the oral triptans but with a faster onset of action.”(3)

SOURCES:

  1. Nautilus Neurosciences, Inc. Announces a New Approval for CAMBIA® for the Acute Treatment of Migraine; Marketwatch -PR Newswire; March 2012; http://www.marketwatch.com/story/nautilus-neurosciences-inc-announces-a-new-approval-for-cambia-for-the-acute-treatment-of-migraine-2012-03-19
  2. Image by Stuart Miles; Freedigitialphotos.net; March 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=2664
  3. Health Canada Approves CAMBIA(R) for the Treatment of Acute Migraine; Marketwatch – Marketwire- Press Release; March 2012; http://www.marketwatch.com/story/health-canada-approves-cambiar-for-the-treatment-of-acute-migraine-2012-03-16

 

Copyrights apply on this blog. Please refer copyright permissions.

Some More Good News For Migraineurs!

Teva Pharmaceuticals U.K have launched generic Naratriptan for migraineurs in the U.K. today. Teva is a pharma major in the U.K with share in the generic drugs, branded respiratory and hospital care market

Teva Pharmaceutical Releases Affordable Generic Naratriptan (1)

The generic Naratriptan is thus a cheaper and more affordable option by migraineurs. The generic Naratriptan is four times cheaper than the branded version of the same chemical (Naratriptan hydrochloride). It has been released as film-coated tablets of potency 2.5 mg in two pack sizes. This generic form targets to manage the acute headache phase of a migraine episode that is accompanied with or without an aura.

According to Teva UK’s Commercial Director, Kim Innes, “We want to make more medicines accessible for more people and Naratriptan is our fifth day-one launch this year to add to our portfolio of over 700 products. It’s good for Pharmacy because patent expiries provide opportunities for increasing margins and keeping costs down. Importantly, it also means we continue to help save the NHS over £9bn on generic prescriptions.” (2)

Naratriptan is a prescription drug that must be taken strictly as per doctor’s instructions. Naratriptan for migraine is contraindicated if the person has high blood pressure, chest pain, diabetes, stroke, liver conditions, kidney disease or epilepsy.

SOURCES:

1. Image by Anankkml; Freedigitalphotos.net; March 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=1674

2. Teva UK Limited Launches Generic Naratriptan; Bloomberg; March 2012; http://www.bloomberg.com/apps/news?pid=conewsstory&tkr=GSK:LN&sid=anAq2w.AQWjI

Copyrights apply on this blog. Please refer copyright permissions.