Originally approved by the FDA in January, sumatriptan nasal spray was acquired by Upsher-Smith in a territory rights agreement with Dr. Reddy’s Laboratories in June, as well as its 3-mg injection formulation (Zembrace SymTouch).
Upsher-Smith Laboratories has announced its launch of sumatriptan (Tosymra) nasal spray to treat migraine acutely in adults with or without aura. The fast-acting agent will be available in a 10 mg dose.1
Originally approved in by the FDA in January 2019, sumatriptan was acquired by Upsher-Smith in a territory rights agreement with Dr. Reddy’s Laboratories, as well as its 3-mg injection formulation (Zembrace SymTouch).
"We're excited to launch Tosymra, the third product in Upsher-Smith's growing migraine portfolio, which includes Qudexy XR and Zembrace SymTouch," Rusty Field, president and CEO, Upsher-Smith, said in a statement. "Many patients face challenges during migraine attacks that make available acute treatment options inadequate. Tosymra Nasal Spray offers an alternative for patients whose symptoms interfere with taking oral medication or who may be dissatisfied with their current treatment regimen."
Under the terms of the agreement, Dr. Reddy's was eligible to receive an upfront payment, future milestone payments, and sales-based royalties. At the time it acquired sumatriptan, Field noted that both formulations were “great strategic fit[s]” for Upsher-Smith’s plans to diversify its product pipeline in migraine.2
The sumatriptan delivery process utilizes the company’s Intravail technology and has been shown to show median peak plasma concentration 5 minutes faster than injectable doses of 4 mg and 6 mg. As well, 2 hours post-administration, a 10-mg dose of demonstrated a significantly increased rate and extent of drug absorption when compared with sumatriptan (Imitrex) 20-mg nasal spray.
Its submission to the FDA was backed by a phase 2 (NCT02856802) randomized, placebo-controlled trial that demonstrated the effectiveness in treating pain and associated symptoms during a migraine attack and in reducing attack-related functional disability in 107 study participants. The primary outcome was the proportion of participants with pain freedom at 2 hours post-dose in the first double-blind treatment period.
A greater proportion of study participants treated with sumatriptan (43.8%) experienced 2-hour pain freedom compared to placebo (22.5%; P <.07). Treatment with the therapy also significantly alleviated the most bothersome symptom, which included nausea, photophobia, and phonophobia, compared to placebo at 2 hours post-dose (70.7% vs. 39.5%; P <.01).
Overall, it was deemed well-tolerated, with adverse events (AEs) experienced including dysgeusia (n = 4), application site pain (n = 2), chest discomfort, burning sensation, rhinorrhea, and malaise (n = 1 all), all rated mild to moderate.3
As is the case with other sumatriptan products, Tosymra is contraindicated in those with a history of coronary artery disease or coronary artery vasospasm; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or history of hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; or severe hepatic impairment. It is not known if DFN-02 is safe and effective in children under 18 years of age.
Upsher-Smith noted that the treatment is supported by its Access Pathways Program, which offers savings and support services for patients, and that its “Platinum Pass savings card enables commercially insured patients to pay as little as $0 per prescription.”
1. Upsher-Smith Laboratories Launches Tosymra™ (sumatriptan) Nasal Spray For The Acute Treatment Of Migraine In Adults [press release]. Maple Grove, MN: Upsher-Smith; Published October 2, 2019. businessinsider.com/news/stocks/upsher-smith-laboratories-launches-tosymra-sumatriptan-nasal-spray-for-the-acute-treatment-of-migraine-in-adults-1028571043. Accessed October 2, 2019.
2. Upsher-Smith Laboratories Enters Into Agreement To Acquire Tosymra™ (sumatriptan nasal spray) And Zembrace® SymTouch® (sumatriptan injection) [press release]. Maple Grove, MN: Upsher-Smith; Published June 13, 2019. prnewswire.com/news-releases/upsher-smith-laboratories-enters-into-agreement-to-acquire-tosymra-sumatriptan-nasal-spray-and-zembrace-symtouch-sumatriptan-injection-300867659.html. Accessed October 2, 2019.
3. Dr. Reddy's Laboratories and Its U.S. Subsidiary, Promius Pharma, Announce FDA Approval for TOSYMRA™ (Sumatriptan Nasal Spray) 10 mg, in the U.S. Market [press release]. Hyderbad, India, and Princeton, NJ: Dr. Reddy’s Laboratories Ltd.; Published January 27, 2019. https://www.businesswire.com/news/home/20190127005042/en/Dr.-Reddys-Laboratories-U.S.-Subsidiary-Promius-Pharma. Accessed October 2, 2019.