Archive for the ‘News’ Category

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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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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Hello, gentle readers. Please excuse my absence from the blog world. Unfortunately, life interrupted my plans and my dear husband and I had to make an unexpected trip to PA. For the last month, instead of searching the web for new Migraine treatments, I was learning all I could about astrocytomas, radiation, and chemotherapy. When the dust settled, all ended ok.  “Benign” is what most people would prefer, but we heard  “malignant” , instead.

However, this was not as dark and desperate as it could have been. The patient is young and the tumor was removed completely. Chemo course is half what most people have to endure.

So now that the worst is behind us, I turn my focus to Migraine. Two articles have been recently published concerning the relation between Migraine and depression. Migraine and depression are comorbid diseases (as any migraineur can attest), but evidently the etiologiy has not been studied. Both of these studies are so new that they are currently not available. Look for updates.

In other news, Lynne Greenberg published her memoir, The Body Broken: A Memoir. I have not yet read the book, but Diana Lee’s post and the exerpt on Amazon were enough to get me to buy the book.

MediClim.com, a website that offers free information regarding the weather and chronic health condidtions. Sign up for the free service and you will get an email a day prior to weather changes that may affect your Migraine disease. Migraineurs could request time off in advance instead of waiting for the Migraine to strike. There are forums available. I joined.

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