OnabotulinumtoxinA: A Review in the Prevention of Chronic Migraine

Abstract

An intramuscular formulation of onabotulinumtoxinA (onabotA; Botox®) is currently the only therapy specifically approved for the prevention of headaches in adults with chronic migraine (CM) in the EU and North America. This article provides a narrative review of relevant data on the drug in this indication from an EU perspective. OnabotA was originally approved on the basis of pooled data from two phase III studies (PREEMPT 1 and 2). In these pivotal studies, injection of up to five cycles of onabotA (155–195 U/cycle) at 12-week intervals was generally well tolerated and effective in producing statistically significant and clinically meaningful improvements in headache symptoms, acute headache pain medication usage, headache impact and health-related quality of life in adults with CM, of whom approximately two-thirds were acute medication overusers and approximately one-third had failed to respond to ≥ 3 prior oral prophylactic therapies. More recently, the efficacy and tolerability of onabotA over a period of 1 year in the PREEMPT programme has been substantiated and extended by the results of a long-term phase IV study (COMPEL), in which patients received up to nine treatment cycles over a period of 2 years, and by findings from several real-world clinical practice studies from Europe, including the prospective multinational REPOSE and CM-PASS studies. In conclusion, the totality of evidence from clinical trials and real-world studies indicates that onabotA is an effective and generally well tolerated option for the prevention of CM that may be particularly useful for patients who have previously failed to respond to or are intolerant of commonly prescribed oral prophylactics.

Peri‐Incisional Botulinum Toxin Therapy for Treatment of Intractable Head Pain After Lateral Skull Base Surgery: A Case Series

“…The presence of migraines in 50% of our cases suggests that migraines may be a risk factor for the development of intractable postoperative HP. 13,14 Two large multicenter, controlled trials, PREEMPTs 1 and 2, demonstrated that onabotA therapy significantly decreased the frequency, duration, and severity of HA episodes in patients with chronic migraines, one-third of whom had failed to respond to greater than 3 oral prophylactic therapies. The overall presence of preoperative headache prior to developing POH was 32%.…”

“…Rimaaja et al echo this finding in that preoperative migraine was present in 77% of patients with preoperative headache who later developed POH after acoustic neuroma resection. 13,14 Its use in the treatment of other forms of HA is less established and many studies show no significant effect; however, a growing body of literature is now suggesting that botulinum toxin can be used for postsurgical pain. 19 In patients #1 and #2, surgical trauma may have aggravated their preexisting condition, as evidenced by the migrainous features of headaches in patient #2.…”

“…20 OnabotA was FDA approved for the treatment of chronic migraines in 2010 and has since become a well-established treatment option. 13,14 Two large multicenter, controlled trials, PREEMPTs 1 and 2, demonstrated that onabotA therapy significantly decreased the frequency, duration, and severity of HA episodes in patients with chronic migraines, one-third of whom had failed to respond to greater than 3 oral prophylactic therapies. 13,14 Its use in the treatment of other forms of HA is less established and many studies show no significant effect; however, a growing body of literature is now suggesting that botulinum toxin can be used for postsurgical pain.…”

“…8,9 Some patients have found relief from surgical therapies, such as occipital nerve excision or cranioplasty. 13,14 However, the effect of botulinum toxin on other forms of head pain (HP) is less established and to our knowledge, there have only been 2 case series investigating the effects of peri-incisional botulinum toxin injections on chronic POH. 12 Onabotulinum toxinA (onabotA) is an FDA approved treatment for chronic migraines with proven efficacy when conservative medical therapy fails.…”

“…12 Onabotulinum toxinA (onabotA) is an FDA approved treatment for chronic migraines with proven efficacy when conservative medical therapy fails. 13,14 However, the effect of botulinum toxin on other forms of head pain (HP) is less established and to our knowledge, there have only been 2 case series investigating the effects of peri-incisional botulinum toxin injections on chronic POH. 15,16 Given the high incidence of POH following lateral skull base surgery, the limited treatment options available, and the significant impact on quality of life, we describe a case series of 4 patients evaluating the role of peri-incisional on-abotA in the treatment of chronic POH after lateral skull base surgery as well as temporoparietal fascial flap harvest.…”