Sumatriptan transdermal iontophoretic patch (NP101-Zelrix™): review of pharmacology, clinical efficacy, and safety in the acute treatment of migraine

Figures & data

Table 1 Comparison of strengths and weaknesses of different routes of administration of acute migraine attack medications: oral, nasal, injectable, and transdermal

Route of administration of acute migraine attack medications	Advantages	Disadvantages
Oral	Patients prefer and know tablets	Gastrointestinal dysfunction may result in delayed absorption but also in postponing or even avoiding the use of tablets
	Convenient, easy to use
	Less expensive
Nasal	Drug bypasses gastrointestinal tract and first pass metabolism; acts despite presence of gastrointestinal dysfunction	A significant portion of drug is swallowed and absorbed in the small intestine
	Faster onset of action than tablet	Some patients do not like nasal administration
	Easy to use
Injectable	Drug bypasses gastrointestinal tract and first pass metabolism; acts despite presence of gastrointestinal dysfunction	Often considered as an invasive, more complicated and uncomfortable choice.
	Fastest onset of action. Most effective at 1 and 2 hours	Higher recurrence rates and more adverse events than other formulations.^Citation14
Transdermal	Drug bypasses gastrointestinal tract and first pass metabolism; acts despite presence of gastrointestinal dysfunction. Easy to use, no injection discomfort, better for those who dislike nasal sprays	Novel technology Patients may be unfamiliar with apparatus Possibility of application site adverse reactions

Figure 1 Principles of iontophoretic drug delivery systems.

Note: A small electrical charge is used to facilitate drug movement from the anode to the cathode and also through the skin.

Figure 2 Results of a randomized, double-blind, placebo-controlled, phase III study of iontophoretic transdermal sumatriptan drug device for acute migraine.

Notes: The primary efficacy endpoint was the proportion of patients who were pain-free at 2 hours. All comparisons are statistically significant. For numbers needed to treat and exact P values, please refer to Table 1.

Table 2 Efficacy results from the phase III trial of the iontophoretic sumatriptan patch^18–20

Efficacy parameter	NP 101 (sumatriptan patch) (%)	Placebo (%)	NNT	P value
Freedom from pain at 2 hours*	18%	9%	11.1	0.0092
Freedom from photophobia at 2 hours	51%	36%	6.66	0.0028
Freedom from phonophobia at 2 hours	55%	39%	6.25	0.00021
Freedom from nausea at 2 hours	84%	63%	4.8	<0.0001
No use of rescue medication	60%	40%	5	<0.0001
Relief from pain at 2 hours	53%	29%	4.2	<0.0001
Relief from pain at 1 hour	29%	19%	10	0.0135
Freedom from nausea at 1 hour	71%	58%	7.7	0.0025
Sustained pain relief for 2 to 24 hours	34%	21%	7.7	0.0015

Note:

* primary endpoint

Abbreviation: NNT, number needed to treat.

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GoldsteinJPugachNSmithTAcute anti-migraine efficacy and tolerability of Zelrix, a novel iontophoretic transdermal patch of sumatriptanResearch abstract presented at 14th International Headache CongressSeptember 10–13, 2009Philadelphia (PA)Headache201050350951520456145

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GoldsteinJSmithTRPugachNA Sumatriptan iontophoretic transdermal system for the acute treatment of migraineHeadache [epub ahead of print].

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