This publish was written and revealed as a collaboration between the in-house editorial group at Benzinga and Tonix Prescribed drugs Holding Corp. with monetary help from Tonix. The 2 organizations work to make sure that any and all info contained inside is true and correct as of the date hereof to the perfect of their information and analysis. This content material is for informational functions solely and never supposed to be investing recommendation.
For millions of individuals residing with migraines, the ache can strike with out warning, usually throughout essentially the most inconvenient occasions – like when they’re quick asleep. The abrupt transition from sleep to a full-blown migraine leaves little room for preemptive motion, particularly when conventional oral migraine drugs can take half an hour to an hour, or much more, to work.
However for these searching for instant aid, Tonix Prescribed drugs TNXP is hoping to alter the sport. Via its subsidiary, Tonix Medicines, the biopharmaceutical firm is advertising two merchandise, Zembrace® SymTouch® (sumatriptan autoinjector) and Tosymra® (sumatriptan nasal spray), each promising potential migraine aid in as little as 10 minutes.
Tonix, recognized for its work in creating new remedies for central nervous system (CNS) circumstances, acquired these migraine drugs to cater to a rising want for quicker, non-oral therapy choices. For individuals who do not expertise the early warning indicators of migraines, reminiscent of auras, or for individuals who get up already within the throes of ache, each minute issues. That is the place Tonix’s merchandise may present a important edge.
Oral Drugs: Sluggish To Soak up, Sluggish To Act
For most individuals, oral drugs are the primary line of protection in opposition to migraines. They’re efficient for a lot of, however not with out limitations. The issue lies of their delayed absorption into the bloodstream, which will be notably problematic throughout a migraine assault. Gastroparesis, a situation the place the abdomen muscle groups decelerate or cease digesting meals, usually accompanies migraines. This delayed digestion could make oral drugs slower or probably ineffective as a result of they aren’t absorbed rapidly sufficient to supply aid.
Tonix’s current awareness campaign, “Does Your Migraine Capsule Work Each Time?” goals to handle this problem head-on. Launched on the 2024 PAINWeek Convention, the marketing campaign educates each migraine victims and healthcare suppliers on the significance of non-oral migraine remedies. Injectables and nasal sprays, which bypass the digestive system, might supply quicker absorption and a faster path to aid, the marketing campaign argues.
“Non-oral migraine drugs, reminiscent of injectables and nasal sprays, don’t depend on the digestive system to be absorbed and may supply the potential for quicker aid from migraine signs in as little as 10 minutes,” mentioned Dr. Deborah I. Friedman, a board-certified neuro-ophthalmologist and headache drugs specialist.
With this in thoughts, Friedman encourages healthcare suppliers to debate non-oral therapy choices with their sufferers, particularly those that haven’t discovered success with conventional capsules.
Zembrace SymTouch: Pace And Simplicity In A Single Dose
Tonix’s Zembrace SymTouch may very well be an answer for sufferers who want migraine aid quick. This injectable formulation of sumatriptan, designed for acute migraine therapy, may present aid in as little as 10 minutes for a portion of customers, the corporate says. Firm medical trials discovered that 17% of sufferers expertise aid inside this transient window, in comparison with simply 5% with a placebo.
However Zembrace SymTouch is not simply quick, it may also be simple to make use of. The product is available in a small auto-injector that requires minimal preparation, making it handy for migraine victims to hold and use on the go. The corporate says the injector options the smallest needle out there amongst sumatriptan injectors, decreasing discomfort for customers. Moreover, it does not require refrigeration, which is a major benefit for individuals who must take their remedy with them.
Tosymra: A Needle-Free, Quick-Appearing Various
Whereas some sufferers are snug with injections, others might favor a needle-free possibility. That is the place Tonix’s Tosymra steps in. A nasal spray model of sumatriptan, Tosymra is designed to ship the identical fast aid as Zembrace SymTouch however utilizing Intravail® know-how, which permits the remedy to be absorbed straight via the nasal mucosa into the bloodstream, bypassing the gastrointestinal tract fully. Within the medical research, some sufferers skilled aid inside 10 minutes after a single spray. By the two-hour mark, 57% of sufferers reported vital ache discount, in comparison with 21% who took a placebo.
The product’s small, discreet design provides to its attraction. For migraine victims who want instant aid with out the effort of needles or capsules, Tosymra gives a transportable, probably fast-acting various that matches simply into a handbag or pocket.
Increasing Past Migraines: Tonix’s Strategic Strikes
Tonix’s give attention to non-oral migraine remedies highlights an necessary potential shift in the way in which migraines are managed. Many individuals with migraines, particularly these experiencing gastroparesis, wrestle with oral drugs as a result of they aren’t absorbed quick sufficient throughout an assault. By providing two totally different non-oral options, Tonix hopes to fill a important hole for individuals who want quicker and extra dependable aid.
Tonix’s acquisition of Zembrace SymTouch and Tosymra from Upsher-Smith Laboratories was not nearly bettering choices for migraine sufferers. The corporate says it was a strategic transfer to construct out Tonix’s industrial infrastructure forward of the FDA submission of its New Drug Software for TNX-102 SL, its candidate for fibromyalgia – a continual ache situation that impacts thousands and thousands.
Fibromyalgia, like migraines, is a dysfunction that usually leaves sufferers grappling with ache administration. If permitted by the FDA, TNX-102 SL may assist to place Tonix as a frontrunner within the broader discipline of ache administration, the corporate says.
Navigating A Aggressive Market
Tonix faces some stiff competitors within the migraine market. In November, the corporate reported $11.3 million in trailing 12 months gross sales for its migraine merchandise, a determine that pales compared to trade giants like Pfizer Inc.’s PFE Nurtec, which recorded $356 million in gross sales throughout the identical interval. In the meantime, AbbVie Inc.’s ABBV Ubrelvy and Qulipta posted mixed gross sales of $381 million.
Tonix’s means to seize extra market share may rely upon how effectively it could possibly unfold consciousness about the advantages of its fast-acting, non-oral remedies.
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This publish comprises sponsored content material. This content material is for informational functions solely and isn’t supposed to be investing recommendation.
Indication and Utilization
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to deal with acute migraine complications with or with out aura in adults who’ve been identified with migraine.
Zembrace and Tosymra aren’t used to forestall migraines. It’s not recognized if Zembrace or Tosymra are protected and efficient in kids beneath 18 years of age.
Necessary Security Data
Zembrace and Tosymra may cause critical negative effects, together with coronary heart assault and different coronary heart issues, which can result in dying. Cease use and get emergency assist when you’ve got any indicators of a coronary heart assault:
- discomfort within the middle of your chest that lasts for various minutes or goes away and comes again
- extreme tightness, ache, stress, or heaviness in your chest, throat, neck, or jaw
- ache or discomfort in your arms, again, neck, jaw or abdomen
- shortness of breath with or with out chest discomfort
- breaking out in a chilly sweat
- nausea or vomiting
- feeling lightheaded
Zembrace and Tosymra aren’t for folks with threat elements for coronary heart illness (hypertension or ldl cholesterol, smoking, obese, diabetes, household historical past of coronary heart illness) except a coronary heart examination reveals no downside.
Don’t use Zembrace or Tosymra when you’ve got:
- historical past of coronary heart issues
- narrowing of blood vessels to your legs, arms, abdomen, or kidney (peripheral vascular illness)
- uncontrolled hypertension
- hemiplegic or basilar migraines. In case you are undecided when you’ve got these, ask your supplier.
- had a stroke, transient ischemic assaults (TIAs), or issues with blood circulation
- extreme liver issues
- taken any of the next medicines within the final 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your supplier for an inventory of those medicines if you’re undecided.
- are taking sure antidepressants, referred to as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or much less because you stopped taking a MAO-A inhibitor. Ask your supplier for an inventory of those medicines if you’re undecided.
- an allergy to sumatriptan or any of the elements of Zembrace or Tosymra
Inform your supplier about your entire medical circumstances and medicines you’re taking, together with nutritional vitamins and dietary supplements.
Zembrace and Tosymra may cause dizziness, weak point, or drowsiness. If that’s the case, don’t drive a automobile, use equipment, or do something the place you must be alert.
Zembrace and Tosymra might trigger critical negative effects together with:
- modifications in colour or sensation in your fingers and toes
- sudden or extreme abdomen ache, abdomen ache after meals, weight reduction, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
- cramping and ache in your legs or hips; feeling of heaviness or tightness in your leg muscle groups; burning or aching ache in your toes or toes whereas resting; numbness, tingling, or weak point in your legs; chilly feeling or colour modifications in a single or each legs or toes
- elevated blood stress together with a sudden extreme improve even when you’ve got no historical past of hypertension
- remedy overuse complications from utilizing migraine drugs for 10 or extra days every month. In case your complications worsen, name your supplier.
- serotonin syndrome, a uncommon however major problem that may occur in folks utilizing Zembrace or Tosymra, particularly when used with anti-depressant medicines known as SSRIs or SNRIs. Name your supplier instantly when you’ve got: psychological modifications reminiscent of seeing issues that aren’t there (hallucinations), agitation, or coma; quick heartbeat; modifications in blood stress; excessive physique temperature; tight muscle groups; or bother strolling.
- hives (itchy bumps); swelling of your tongue, mouth, or throat
- seizures even in individuals who have by no means had seizures earlier than
The commonest negative effects of Zembrace and Tosymra embrace: ache and redness at injection website (Zembrance solely); tingling or numbness in your fingers or toes; dizziness; heat, scorching, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or drained; utility website (nasal) reactions (Tosymra solely) and throat irritation (Tosymra solely).
Inform your supplier when you’ve got any facet impact that bothers you or doesn’t go away. These aren’t all of the potential negative effects of Zembrace and Tosymra. For extra info, ask your supplier.
That is an important info to learn about Zembrace and Tosymra however just isn’t complete. For extra info, discuss to your supplier and skim the Patient Information and Instructions for Use. You too can go to https://www.tonixpharma.com or name 1-888-869-7633.
You might be inspired to report opposed results of pharmaceuticals to the FDA. Go to www.fda.gov/medwatch, or name 1-800-FDA-1088.
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