Tosymra® delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).*1-3
Efficacy of Tosymra® is based on relative bioavailability to subcutaneous sumatriptan at a dose of 4 mg. In a clinical study, this dose of sumatriptan resulted in 57% of patients achieving pain relief at 2 hours vs. 21% for placebo.1
*Time to onset and degree of pain relief varies by patient.
Give your patients options
Oral therapy may not be the optimal treatment for every migraine. See why Tosymra® uses the novel ingredient Intravail®.
Tosymra® achieved peak plasma concentration
8x faster than Imitrex® nasal spray4
Mean sumatriptan plasma concentration-time profile
Results from a randomized, crossover, pilot pharmacokinetic study conducted in 18 healthy adults.4 In this study, three AEs occurred with Tosymra® (vomiting, paresthesia and burning sensation in nose). Three AEs occurred with Imitrex® (sumatriptan) 20 mg nasal spray (nausea and throat irritation [two events]). All events were mild or moderate in intensity.5
Tosymra® uses the science of Intravail®
Tosymra® is the first and only triptan nasal spray to use the novel ingredient Intravail® to enhance drug absorption across the nasal mucosa.6
Controlled transient permeation of the nasal mucosa6
Intravail® is thought to facilitate paracellular absorption by transiently relaxing tight junctions, allowing drug access to systemic circulation, among other mechanisms.6-8
Tosymra® is a sumatriptan nasal spray with mist-like administration
The safety profile of Tosymra® is generally consistent with that of subcutaneous injectable sumatriptan.
Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
Additional common adverse reactions with Tosymra® include the local irritative symptoms of application site reaction, dysgeusia, and throat irritation.
In a 6-month open-label, repeat-dose safety study designed to assess the safety and tolerability of Tosymra® in 167 adult patients, Tosymra® was well-tolerated, with a low rate of triptan-related adverse events (TEAEs).9 Over the course of the 6-month study, 3,292 doses of Tosymra® were used to treat 2,211 migraine attacks.10
|Most common TEAEs|
(≥5% of subjects)
|Application site pain*||51 (30.5%)||568||17.3%|
|Upper respiratory tract infection||18 (10.8%)||24||0.7%|
|Application site reaction||9 (5.4%)||32||1.0%|
†Percent of patients experiencing the event at least once during the course of the study.
††Only one event of sinusitis was considered “possibly related” to Tosymra®.
- 5 patients (3%) discontinued due to adverse events.10
- Overall, 2.9% of doses were associated with a triptan-related TEAE.10
- The majority of triptan-related adverse events were mild; none were severe.9
Redefining patient-centric treatment
Upsher-Smith Laboratories, LLC has never wavered in our desire to offer people high-quality products that could help improve their health and lives. Having served patients for over a century, we take pride in providing attentive customer service, having strong industry relationships and being dedicated to uninterrupted supply.
Making migraine our priority
A variety of dosage forms and delivery options for known and trusted molecules ensures you have a variety of medication options that can address the unique needs of patients with migraine.
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- Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: 2019.
- Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.
- Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.
- Munjal S, et al. A randomized trial comparing the pharmacokinetics, safety, and tolerability of DFN-02, an intranasal sumatriptan spray containing a permeation enhancer, with intranasal and subcutaneous sumatriptan in healthy adults. Headache. 2016;56(9):1455-1465.
- Data on file. Upsher-Smith Laboratories, LLC, Maple Grove, MN.
- Maggio ET. Intravail®: Highly effective intranasal delivery of peptide and protein drugs. Expert Opinion Drug Delivery. 2006;3(4):529-539.
- Maggio ET, Pillion DJ. High efficiency intranasal drug delivery using Intravail® alkylsaccharide absorption enhancers. Drug Deliv Transl Res. 2013;3(1):16-25.
- Ghadiri M, Young PM, Traini D. Strategies to enhance drug absorption via nasal and pulmonary routes. Pharmaceutics. 2019;11(3):113.
- Munjal S, et al. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017;18(1):31.
- Halvorsen MB, et al. Triptan-related adverse events in a multicenter, open-label, long-term, safety study of DFN-02 (Tosymra®; an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM), for the acute treatment of migraine. PAINWeek Conference 2019; September 3-7, 2019; Las Vegas, NV.