Chronic Migraine

Chronic Migraines is a highly disabling chronic pain syndrome resulting in loss of productivity, medication overuse as well as psychiatric comorbidities, such as depression and anxiety.

Indication

BOTOX® for injection is indicated for the prophylaxis of headaches in adult patients with Chronic Migraine (≥ 15 days per month with

Headaches lasting 4 hours a day or longer).

 

 

 

FDA approved since 2010 for use in chronic migraines.

Clinician administered intra muscular injections across seven specific head and neck areas

Administered by clinician every 12 weeks

Covered by all insurances including medicare. For commercial insurances, even with deductibles, the out of pocket cost is $ 0

 

Clinical Evidence

The largest randomized clinical trials that evaluated the efficacy of OBOT-A in CM were the PREEMPT-1 and PREEMPT-2 studies.  Analysis of the primary endpoint for the efficacy from the pooled data set revealed that OBOT-A significantly reduced the number of headache days per 28-day cycle relative to placebo at week 24 [1]

The pooled analysis of Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT)-1 and PREEMPT-2 studies revealed that long-term treatment with OBOT-A was highly effective in reducing headache frequency and was generally safe and well tolerated as a prophylactic medication of CM [2,3,4,5].

A study analyzing long-term experience with OBOT-A in CM demonstrated that after an average of two years treatment with OBOT-A in responder CM patients the need for acute pain medication was decreased by 53% and emergency visits were reduced by 61% [6]

In a recent clinical trial, CM patients with medication overuse were studied after a five-day-long withdrawal period with 150 U OBOT-A injection, which confirmed the efficacy of OBOT-A [7].

Results of another clinical study in which OBOT-A was used in the dose of 155 U, in accordance with the PREEMPT study protocol, showed that the number of headache days per month and the acute medication intakes decreased significantly in the treatment group [8]

A recent prospective post-marketing cohort analysis in a real-life clinical setting demonstrated that OBOT-A significantly reduced the number of headache and migraine days, and showed a capability to increase the numbers of headache-free days [9].

 

References:

  1. Dodick D.W., Turkel C.C., DeGryse R.E., Aurora S.K., Silberstein S.D., Lipton R.B., Diener H.C., Brin M.F., PREEMPT Chronic Migraine Study Group OnabotulinumtoxinA for treatment of chronic migraine: Pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010;50:921–936. doi: 10.1111/j.1526-4610.2010.01678.x.
  2. Vecsei L., Majlath Z., Szok D., Csati A., Tajti J. Drug safety and tolerability in prophylactic migraine treatment. Expert Opin. Drug Saf. 2015;14:667–681. doi: 10.1517/14740338.2015.1014797.
  3. Ashkenazi A., Blumenfeld A. OnabotulinumtoxinA for the treatment of headache. Headache. 2013;53:54–61. doi: 10.1111/head.12185.
  4. Dodick D.W., Turkel C.C., DeGryse R.E., Aurora S.K., Silberstein S.D., Lipton R.B., Diener H.C., Brin M.F., PREEMPT Chronic Migraine Study Group OnabotulinumtoxinA for treatment of chronic migraine: Pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010;50:921–936. doi: 10.1111/j.1526-4610.2010.01678.x.
  5. Tajti J., Szok D., Tuka B., Csati A., Kuris A., Majlath Z., Lukacs M., Vecsei L. Botulinum neurotoxin—A therapy in migraine. Ideggyogy. Szle. 2012;65:77–82.
  6. Cernuda-Morollon E., Ramon C., Larrosa D., Alvarez R., Riesco N., Pascual J. Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: What happens after one year? Cephalalgia. 2014 doi: 10.1177/0333102414561873.
  7. Grazzi L. Onabotulinum toxin A for treatment of chronic migraine with medication overuse. Neurol. Sci. 2013;34:S27–S28. doi: 10.1007/s10072-013-1381-1.
  8. Grazzi L., Usai S. Botulinum toxin A: A new option for treatment of chronic migraine with medication overuse. Neurol. Sci. 2014;35:37–39. doi: 10.1007/s10072-014-1739-z.
  9. Khalil M., Zafar H.W., Quarshie V., Ahmed F. Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, U.K. J. Headache Pain. 2014;15:54. doi: 10.1186/1129-2377-15-54.