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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De-mystifying Migraines In Women

I was struck by the statistics on migraineurs worldwide published by the WHO. Apparently, 303 million people the world over suffer migraines, out of which women account for 70% of the patients. India alone has 100 million sufferers and the US has 30 million patients. The report went on to add that it is estimated that 20 million migraine attacks happen everyday!!!! Staggering by any scale.

Though a lot of cutting edge research has been done, especially in the last decade to control this beast, scientific reports still grapple with unknowns, and are still clueless on issues such as why or how magnesium release regulates calcium ions in the neurons or why a certain chain of events takes place in the cranium that bring on migraines or even why they wind up.

With so much still in the grey, one wonders when and if help will come from drugs that will be safe to consume in the long run or if there are any strategies out there to shake this neurological disease.

In my book, ‘Migraines for the Informed Woman’, I have attempted to simplify the esoteric jargon of research papers and scientific material on migraines. After more than one decade of trying most therapies, I have come to the conclusion, that some work and others that are not as effective. More importantly, I have come to realise that certain mixes of therapies done simultaneously work wonders.

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