Abstract
The acute treatment of migraine requires effective drugs that are well tolerated and provide rapid and consistent pain relief. Oral tablets are the most commonly used acute treatment for migraine; however, their effectiveness is limited by the rate of gastrointestinal (GI) tract absorption and first-pass hepatic metabolism, and they may not be ideal for patients experiencing GI motility issues. Nasal delivery is an attractive alternative route as it may circumvent GI tract absorption, avoid first-pass metabolism in the liver, and potentially reduce the frequency of GI adverse events. The large surface area and high vascularity within the nose may permit rapid absorption of therapeutics into the systemic circulation, allowing for rapid onset of action. However, the site of drug deposition (upper versus lower nasal cavity) may influence drug pharmacokinetics. Most approved nasal migraine therapies target the lower nasal space where the epithelium is less permeable, and they may be quickly cleared away due to increased ciliary function or dripping from the nose or swallowing, resulting in variable absorption and limited bioavailability. Together with its abundant vascularization, relative mucosal thickness stability, and low clearance rates, the upper nasal space harnesses the benefits of nasal delivery to potentially maximize drug efficacy.
Highlights
Migraine is a debilitating condition, representing the second leading cause of disability globally [1,2,3,4]
One multicenter, randomized, doubleblind, placebo-controlled, single-attack study is described in the United States Prescribing Information (USPI), which reported that a significantly greater percentage of patients achieved headache relief at 2 h with 22 mg ONZETRA Xsail compared to placebo (68% versus 45%, p < 0.05) [70,72]
Studies have suggested that nasal delivery of some triptans provides more rapid onset with greater efficacy compared with oral triptan tablets [66,71]
Summary
Migraine is a debilitating condition, representing the second leading cause of disability globally [1,2,3,4]. Alternative routes of administration for the acute treatment of migraine include injection (subcutaneous (SC), intramuscular (IM), or intravenous (IV)), transdermal, and inhalation (nasal and pulmonary) [17,19,20]. Advantages of inhaled delivery include at-home administration, non-invasiveness, and easy self-administration as well as avoidance of drug degradation in the GI tract and first-pass metabolism (similar to injection), which allows for enhanced bioavailability and reduction of systemic side effects without the use of a needle [22,23]. Reduced olfactory acuity was reported by patients who experienced osmophobia and odor-triggered headaches [28]. Such evidence underpins a connection between the nose and migraine, and a nasal treatment may make more logical sense than previously appreciated. The nose is a complex organ and the need to deliver efficacious medication to the appropriate anatomical region of the nose may have been underestimated
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