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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