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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Superior Acute Migraine Treatment Through Transcept & SNBL Deal

277px-Dihydroergotamine.svg

New drug combines combines a muco-adhesive drug carrier of active DHE with a proprietary nasal powder drug delivery device (1)

A new drug that is poised as a rapidly absorbed chemical in the treatment of acute migraines is now on the horizon. The principal or active chemical in the new drug is dihydroergotamine or DHE.

It is anticipated that DHE which for patenting process is known as TO-2070 will provide a novel and potentially improved approach to treatment of acute migraines in patients. TO-2070 is based on a novel nasal powder drug delivery technology. The technology which is developed by Shin Nippon Biomedical Laboratories (SNBL) combines a muco-adhesive drug carrier with a proprietary nasal powder drug delivery device.

Actually DHE is a well-known treatment for treatment of acute migraines and is being used in the US since 1946, however its delivery via the liquid nasal spray route, the subcutaneous route, via intramuscular injections or intravenous shots is hindered by inconvenient administration regimen, slow onset of relief, inconsistent absorption, post-nasal drip and bitter taste. DHE delivery via the pulmonary inhalation method has still not obtained a nod from FDA.

As per the preclinical data this new drug could offer a considerable range of benefits to the migraineur. Such benefits as are not provided by the currently available delivery methods such as injections, pulmonary inhalation etc which prove more inconvenient as well as invasive by nature. (2)

Both Transcept and SNBL have announced that they have entered into an exclusive global licensing agreement. Transcept will pay SNBL an upfront fee, charges through the developmental milestones of the drug as well as following launch and commercialization. This deal will provide Transcept with an advanced nasal powder delivery device and preclinical and clinical services to support the development of TO-2070.

According to Alan Rapoport, M.D., Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA, Los Angeles, CA, and President of the International Headache Society, “DHE has proven to be an excellent treatment for many of the migraine patients who have tried it. This medication can work quickly depending on how it is administered, provides long-lasting relief, has demonstrated a low migraine recurrence rate and can be effectively administered late in the migraine process. Despite these important advantages, the therapeutic impact of DHE has been somewhat limited by challenges associated with the effective delivery of the drug. With this in mind, a novel delivery system that enables the administration of DHE in a convenient way and offers patients rapid and sustained migraine relief, would represent an important advance in the treatment of migraine.” (3)

SOURCES

  1. Image Credits: File:Dihydroergotamine.svg; Wikipedia.com – Wikipmedia Commons; Web September 2013; http://en.wikipedia.org/wiki/File:Dihydroergotamine.svg
  2. Transcept, SNBL Sign Global Licensing Deal For Advanced Acute Migraine Treatment; RTT News; Web September 2013; http://www.rttnews.com/2193740/transcept-snbl-sign-global-licensing-deal-for-advanced-acute-migraine-treatment.aspx?type=bn
  3. Transcept And Shin Nippon Biomedical Laboratories Announce Global Licensing Agreement For Advanced Acute Migraine Treatment; Market Watch – The Wall Street Journal; Web September 2013; http://www.marketwatch.com/story/transcept-and-shin-nippon-biomedical-laboratories-announce-global-licensing-agreement-for-advanced-acute-migraine-treatment-2013-09-25

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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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