What Should Work, What Might: Migraine Meds Reassessed

ID-100308698

New Studies Re-assesses Migraine Drug Efficacies (1)

Efficacy of migraine drugs was under another new review from researchers who have examined all of the scientific literature available on the treatment as well as followed up on migraine patients and the scientists have come up with what in their view prove effective in acute cases of migraine. Besides these 2 criteria the study was also based on the depth of the published research done on the medications as well as the quantum of studies on them.

The conclusions of the new study at a glance are:

DEEMED EFFECTIVE (LEVEL A) PROBABLY EFFECTIVE (LEVEL B)
TRIPTANS – Sumatriptan, Zolmitriptan, Rizatriptan, Frovatriptan, Almotriptan, Naratriptan, Eletriptan, Avitriptan OPIOID – Codeine+Acetaminophen, Tramadaol+Acetaminophen
Dihydroergotamins
NSAID – Aspirin, Ibuprofen, Naproxen
OPIOID – Butorphanol Nasal Spray
Caffeine with NSAIDS

Findings of the study were published in the January 2015 issue of the medical journal Headache. As per Dr. Stephen Silberstein , professor of neurology and director of the Jefferson Headache Center of Thomas Jefferson University in Philadelphia, “We hope that this assessment of the efficacy of currently available migraine therapies helps patients and their physicians utilize treatments that are the most appropriate for them.” (2)

Based on the study criteria, drugs were thus rated as deemed effective (Level A), probably effective (Level B), possibly effective (Level C). For such medications where the proof was found either inadequate or gave such results which refutes the use of that medicine, was classified as Level U. For a drug to be classified as deemed effective or a Level A drug, the studies done on the drug must be supported by at least well-designed, double-blind, randomized, placebo-controlled clinical trials.  (3)

The American Headache Society will soon be translating the research findings that will aid in providing evidence-based guidelines to clinical practice. In any case, doctors treating migraine patients must consider the individuals on a case to case basis keeping in view the drug side-effects, patient history, costs and drug efficacy.

SOURCES

  1. Image credit: Pills and Capsules – Stock Photo; freedigitalphotos.net; Web February 2015; http://www.freedigitalphotos.net/images/pills-and-capsules-photo-p308698
  2. Study Rates Migraine Medications; WebMD.com; Web February 2015; http://www.webmd.com/migraines-headaches/news/20150120/study-rates-migraine-medications
  3. American Headache Society Provides Updated Assessment of Medications to Treat Acute Migraine; Newswise.com; Web February 2015; http://www.newswise.com/articles/american-headache-society-provides-updated-assessment-of-medications-to-treat-acute-migraine

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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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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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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/

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OptiNose – New Migraine Treatment: Data Presented At IHC 2013

TE_optinoseOptiNose’s Breath Powered Nasal Delivery Device (1)

Drug delivery technology corporation OptiNose Inc. has presented results of a pivotal phase III TARGET study at the International Headache Congress at Boston comparing both the efficacy and the safety of it’s newly developed technology – the OptiNose Breath Powered nasal delivery device with other drug delivery systems and placebos. The abstracts are to be published in Cephalalgia, the Journal of the International Headache Society

The breath-powered device containing low dose sumatriptan was used to deliver the drug in patients experiencing moderate to severe migraine pain, and then compared to placebo administered via the same route later.

According to Ramy A. Mahmoud, M.D., M.P.H., Chief Operating Officer of OptiNose, “Various data we are presenting today will highlight how this novel delivery technology improves the delivery of medicine to hard-to-reach regions deep in the nasal cavity, how it can produce fast and efficient absorption of medicine into the blood, and how effective treatment with this technology can be. There are nearly 30 million migraine sufferers in the United States and many will be able to benefit from a new low-dose treatment that can rapidly provide effective pain relief with few adverse events.” (2)

Sections discussed in the International Headache Congress 2013 included:

  • Efficacy and Safety of a Novel Breath Powered Powder Sumatriptan Intranasal Treatment for Acute Migraine;
  • Data from a randomized, single-dose, four-way cross-over study assessing the absorption into the blood of sumatriptan intranasal powder administered using the  Breath Powered OptiNose drug delivery device compared to Imitrex® subcutaneous injection, Imitrex nasal spray and Imitrex oral tablets in healthy adult volunteers.
  • A review of evidence for human in vivo drug deposition patterns in different regions of the nose with devices intended to provide reliable and efficient drug delivery to upper/posterior nerve structures deep in the nasal cavity.

To know more about the TARGET study, please visit the OptiNose website link given below. (3)

SOURCES:

  1. Image Credit: Nansen Neuroscience Netwrok; Optinose: Novel Nasal Drug Delivery device; Web June 2013; http://www.nansenneuro.net/news/member-news/285-novel-nasal-drug-delivery-device.html
  2. OptiNose AS to Present Data Highlighting New Migraine Treatment at International Headache Congress; BioSpace.com; Web June 2013; http://www.biospace.com/news_story.aspx?StoryID=301426&full=1
  3. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating The Efficacy And Safety Of A Single 20 Mg Dose Of Sumatriptan Powder Delivered Intranasally With The Bi-Directional Device In Adults With Acute Migraine With Or Without Aura; TARGET Phase III Study; Optinose.com; Web June 2013; http://www.optinose.com/clinical-trials/target-clinical-trial-for-migraine

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What the Migraineurs Should Know About The Triptan Drugs

(Source: http://tinyurl.com/l332mz )

Triptans are the relatively new weaponry in the scientists’ arsenal in migraine management and treatment. They work at the neurochemical (serotonin receptor) level. Triptans are not painkillers. All the Triptan drugs act at the wall of the blood vessels (especially cranial/dural blood vessels) and cause their constriction (or narrowing) called vasoconstriction, thus offsetting the swelling that causes the pain. It is also effective in alleviating some of the other symptoms of migraine attack such as sensitivity to light and sound. It acts towards stimulating the release of serotonin in the bloodstream.

Triptan range of medication includes chemicals Frovatriptan, Naratriptan, Eletriptan, Sumatriptan, Almotriptan and Rizatriptan. They should however, never be mixed with ergotamine drugs or any other drug stated in the drug literature or by the doctor. In addition, they are not to be taken in conjunction with any anti-depressant that is known to increase serotonin levels. Neither are they indicated for use by hemiplegic and basilar artery migraineurs.

All of these medications have similar possible side effects such as those of dizziness, fatigue, tingling sensations on skin, dryness of mouth, hot flashes, chest pain or tightness, sensitivity to temperatures, joint pains, coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation, serotonin syndrome etc.

Triptan drugs are available at pharmacies on showing a doctor’s prescription due to the potential side effects, which may be serious in nature. Some Triptan drugs work faster than the others do. Some others work for longer hours, some have only one set of side effects, and the other Triptans may have another set. This makes it imperative for you to consult your doctor before taking these medications. The doctor will make a decision on a case-to-case basis depending on your migraine frequency, intensity, duration, medical history (especially those of heart, diabetes and hypertension etc).

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