• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Tosymra (sumatriptan) nasal spray

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Tosymra (sumatriptan) nasal spray

  • Profile

Profile

Contact Information

Contact: Upsher-Smith Laboratories
Website: https://www.tosymra.com/

Currently Enrolling Trials

    Show More

    General Information

    Tosymra is a nasal spray formulation of sumatriptan, a selective 5-HT1B/1D receptor agonist. 

    Tosymra is specifically indicated for the acute treatment of migraine with or without aura in adults.

    Tosymra is supplied as a spray for intranasal administration. The recommended dose is 10 mg given as a single spray in one nostril. The maximum cumulative dose that may be given in a 24-hour period is 30 mg, with doses separated by at least one hour. Tosymra may also be given at least one hour following a dose of another sumatriptan product. 

    Mechanism of Action

    Tosymra (sumatriptan) is a sulfonamide triptan with vasoconstrictor activity. Sumatriptan selectively binds to and activates serotonin 5-HT1D receptors in the central nervous system (CNS), thereby constricting cerebral blood vessels. This may lead to a relief in pain from vascular headaches. Sumatriptan may also relieve vascular headaches by decreasing the release of vasoactive neuropeptides from perivascular trigeminal axons in the dura mater during a migraine, by reducing extravasation of plasma proteins, and by decreasing the release of other mediators of inflammation from the trigeminal nerve.

    Side Effects

    Adverse effects associated with the use of Tosymra may include, but are not limited to, the following:

    • tingling
    • dizziness
    • feeling warm or hot
    • burning feeling
    • feeling of heaviness
    • feeling of pressure
    • flushing
    • feeling of tightness
    • numbness
    • application site (nasal) reactions
    • abnormal taste
    • throat irritation

    Clinical Trial Results

    The efficacy of Tosymra was based on the relative bioavailability of Tosymra nasal spray compared to sumatriptan subcutaneous injection (4 mg) in healthy adults. Following nasal administration of 10 mg of Tosymra in 73 healthy adults, the relative bioavailability of Tosymra was approximately 87% of that obtained following 4 mg subcutaneous injection of sumatriptan. The relative bioavailability of Tosymra was approximately 58% of that obtained following 6 mg subcutaneous injection of sumatriptan. 

    Tosymra was evaluated in a phase II multicenter, double-blind study conducted in 107 subjects with episodic migraine. The subjects were randomized to receive either Tosymra or placebo to treat a migraine attack with a moderate or severe pain level. The primary endpoint was the proportion of subjects with migraine pain freedom at 2 hours postdose (2hPF). Data showed there was a significantly higher proportion of subjects who experienced 2hPF with Tosymra  compared with placebo: 43.8% (n=48) versus 22.5% (n=40). Tosymra was also significantly better than placebo at alleviating the patients' most bothersome symptom (MBS), including nausea, photophobia, and phonophobia (70.7% versus 39.5% MBS free at 2 hours postdose).

    Approval Date: 2019-01-01
    Company Name: Upsher-Smith Laboratories
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Revamp-360x240.png

      Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

    • AskTheExpertsGreen-360x240.png

      Ask the Experts: Managing Investigational Products

    • SurveywBlueBackground-360x240.png

      Survey Outlines Site Challenges, Successes on Diversity

    • PatientCentricity-360x240.png

      Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing