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Archive for May, 2009

Hi all,

Just a quick note on which comments I will not approve.

  1. Comments that promote or even mention products that promise Migraine relief or cures. This excludes products or medications that are undergoing or have undergone randomized, double-blind studies. Studies must have been published in peer-reviewed journals. recognized by the medical community.
  2. Comments that are intended to harass, demean, or ridicule anyone.
  3. Comments that are intended to provoke arguments with the author or anyone posting legitimate comments.
  4. Comments that contain a link promoting a service or product. This includes links within a signature. This includes links to blogs that are essentially advertisements.

I do not intend to censor legitimate comments that promote resonable discussion. Therefore, if anyone has written such a comment that was not approved, please let me know.

Blessings,

Debbie

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Levadex, MAP Pharmaceuticals’  orally inhaled medication for acute migraine, has met all 4 of the Phase 3 endpoints. In a news release issued on May 26, 2009 MAP Pharmaceuticals stated,

Patients taking LEVADEX therapy (formerly referred to as MAP0004) had statistically significant improvement at two hours compared to patients on placebo for each of the primary endpoints:  Pain relief,…Phonophobia… Photophobia,…and  Nausea….

Relief from nausea was particularly notable with more than two thirds of the study population gaining relief.

The Phase 3 study population of 792 Migraine sufferers had more severe migraine pain than expected with 100% experiencing moderate or severe pain.

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courtesy of the Binghamton News

courtesy of the Birmingham News

Lynne Greenberg has done an amazing job writing about her relationship with chronic pain! My words can not do it justice. Lynne uses poetry to convey the emotion and the metaphors connected to her life with pain. Milton’s Paradise Lost is apt.

Her paradise lost was a promising career as a professor of English (17th century poetry is her passion) at Hunter College, a devoted husband and two children, and a host of friends. Then one day in August 2006 the Headache appeared and has not left. I was hoping for a resolution, some treatment that would remove her pain, or at least relieve it. Now, this is not to be, but she has learned to live with pain and re-enter life.

One lesson she learned is pacing. No, not the frenetic movements accompanying my trying to outrun a Migraine. Instead, it is slowing down enough to manage it. Poet T. S. Eliot describes it as”measuring out my life with coffee spoons” (The Love Song of J. Alfred Prufrock). What seems like a particularly dull life contains a lesson. Pace myself. I only have so many coffee spoons. Learn to say, no; take a break; slow down. All these can seem so simple to a healthy person, but to one coping with chronic pain, they represent tough choices and sacrifices. It is a necessity, not an option.

The book is an easy read, which may tempt readers to rush through it. I caution you to resist that temptation. Take it slowly; savor each chapter; let the lessons pain teaches become part of your life.

Grace,

Debbie

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May 1, 2009 (Wow May already!) Early in 2008 Botox was associated with serious respiratory side effects and even death. Therefore, the FDA is revising the safety warnings and requiring a “Risk Evaluation and Mitigation Strategy” or REMS on the packaging.The drug is used for a variety of conditions including cosmetic enhancement, treatment of blepharospasm and severe dystonia. It is also used for off-label conditions such as spasticity in cerebral palsy, chronic Migraine, and MS. Dosages vary with larger doses for dystonia and spasticity. Read the whole story.

This is all well and good. However, how many patients know that there are severe side effects? How many of us have even SEEN the package insert? I may be naive, but I didn’t see it nor did I think to ask.

The upside is that Allergan is seeking FDA approval for using Botoxfor chronic migraine. Nothing really will have changed, but I guess there is some comfort knowing that Botox is an approved drug for migraine.

Older news:

Topomax or topiramate has gone generic as of April 1, 2009. The FDA reported that the drug would be marketed by a host of pharmaceutical companies including Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc.,  and Barr Laboratories Inc.. One significant difference is that the prescribing information and labelling will differ from the brand name because not all of the patents and exclucivities have expired. Therefore, generic topiramate has been approved for siezures only. That is not to say that it won’t be prescribed off label for migraine prevention.

Along with Topamax becoming available in generic form, Johnson and Johnson is cutting 900 jobs in the Ortho-McNeil-Janssen unit due to a 35%sales decline for Risperdal, its biggest seller. Most of the job cuts will affect pharmaceutical representatives. So I guess having generic drugs available can be a detriment to some.

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