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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
Nasal mucosa
Tosymra® is a sumatriptan nasal spray with mist-like administration
The safety profile of Tosymra® is generally consistent with that of subcutaneous injectable sumatriptan.
ADVERSE REACTIONS:
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.
Tolerability
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) |
Patients† n(%)9 |
Total events n5 |
Incidence per individual dose5,9 |
|---|---|---|---|
| Application site pain* | 51 (30.5%) | 568 | 17.3% |
| Dysgeusia | 35 (21.0%) | 232 | 7.0% |
| Upper respiratory tract infection | 18 (10.8%) | 24 | 0.7% |
| Nasopharyngitis | 12 (7.2%) | 13 | 0.4% |
| Sinusitis†† | 11 (6.6%) | 12 | 0.4% |
| Application site reaction | 9 (5.4%) | 32 | 1.0% |
*Included nasal or nostril burning or stinging.
†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®.
†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.
References:
- 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.